Gynecomastia
Conditions
Keywords
Renuvion, Helium Plasma
Brief summary
This is a prospective, multi-center, single-blinded, randomized study of up to 10 study subjects undergoing bilateral gynecomastia surgery with Renuvion APR System used as an adjunct procedure on one side. The study was conducted at a single investigational center in the United States.
Detailed description
This is a prospective, multi-center, single-blinded, randomized study of up to 10 study subjects undergoing bilateral gynecomastia surgery with Renuvion APR System used as an adjunct procedure on one side. The study was conducted at a single investigational center in the United States. At baseline, the grade of gynecomastia was recorded by side, male chest measurements will be taken, and pre-surgery photographs taken in the frontal, lateral, and oblique views. The gynecomastia surgery and Renuvion APR System use were as per investigator's standard clinical practice. During the procedure, fat transfer and treatment of the lateral chest and/or axilla was not allowed. The Renuvion APR System was used on one side only. The Renuvion treated side was randomized and the patient was blinded as to which side of the chest received Renuvion. Procedure data and adverse events were captured. Endermology was not allowed post-procedure. Post-procedure compression was used for 2-3 weeks with a standard compression vest for all subjects. Follow-up images, grade of gynecomastia, and male chest measurements were taken at D30/D90/D180. All images were assessed for correct identification of Renuvion-treated side by blinded Independent Photographic Reviewers (IPR) following the D180 visit. Following study participation, the subject was offered an optional balancing treatment to the side not previously treated with Renuvion.
Interventions
DEVICERenuvion APR System
The Renuvion APR Handpiece (K191542) is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. The Renuvion APR Handpiece is compatible with the Electrosurgical Generators BVX-200H/P (K170188), and APYX-JS3/RS3 (K192867) owned by Apyx Medical that are indicated for delivery of radiofrequency energy and/or helium gas plasma to cut, coagulate, and ablate soft tissue during open and laparoscopic surgical procedures.
PROCEDUREGynecomastia Correction Surgery
Gynecomastia correction surgery as per the investigators standard treatment of care utilizing liposuction.
Sponsors
Apyx Medical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male subjects, ages 18 - 75 years old. 2. ASA Physical Status Classification System Class I and Class II subjects. 3. Clinical diagnosis of primary or secondary Gynecomastia. 4. Gynecomastia Rohrich Grade IIA or higher. 5. Symmetrical gynecomastia Rohrich grades. 6. Symmetrical chest measurements (no more than 3% variance between sides). 7. Scheduled for Gynecomastia surgery. 8. Willing to have Renuvion APR System as an adjunct procedure on one side understanding that an optional balancing procedure may be provided post-study exit. 9. Understands and accepts the obligation not to undergo any other procedures or treatments in the areas to be treated during study participation. 10. Absence of physical conditions unacceptable to the investigator. 11. Willing and able to comply with protocol requirements, including study-required images/photos, assessments/measurements, and returning for follow-up visits. 12. Willing to release rights for the use of study photos, including in publication. 13. Able to read, understand, sign, and date the informed consent.
Exclusion criteria
1. Subjects without clinical diagnosis of primary Gynecomastia and/or a clinical diagnosis of gynecomastia with secondary causes such as medications, drugs, or testicular tumors. 2. Subjects presenting with ASA Physical Status Classification System Classes III or higher. 3. Gynecomastia Rohrich Grade I. 4. Non-symmetrical gynecomastia Rohrich grades. 5. Non-symmetrical chest measurements (more than 3% variance between sides). 6. Previous treatment or surgery in the breast area. 7. Active systemic or local skin disease that may alter wound healing. 8. Significant or uncontrolled medical condition that in the opinion of the investigator participation in the study may compromise the patient's health. 9. History of autoimmune disease (excluding Hashimoto's thyroiditis). 10. Known susceptibility to keloid formation or hypertrophic scarring. 11. Cancerous or pre-cancerous lesions in the area to be treated. 12. Possesses a surgically implanted electronic device (i.e. pacemaker). 13. Serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in the past two years. 14. Use of endermology post-procedure for the duration of the study. 15. Participation in any other investigational study within 30 days prior to consent and throughout study participation. 16. Subject who, in the opinion of the investigator, is not an appropriate candidate for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Analysis of Bilateral Occurrence of Adverse Events | Through Day 180 | Analysis of bilateral occurrence of adverse events by study arm. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bilateral Analysis of Change to Soft-Tissue Pinch Thickness at the Inframammary Fold | Day 30, 90, 180 | A measurement of soft-tissue pinch thickness at the inframammary fold by isolating skin and subcutaneous tissue at the inframammary fold, pinching firmly, and measuring the thickness with a caliper. |
| Bilateral Analysis of Male Chest Measurements | Day 30, 90, 180 | Measurement of suprasternal notch to nipple, inter-nipple distance, suprasternal notch to nipple plane, midclavicular point to nipple, nipple plane to umbilicus, umbilicus to pubic symphysis, coracoid process to nipple plane, nipple plane to medial epicondyle, and coracoid process to medial epicondyle. |
| Bilateral Analysis of the Amount of Skin Excised During the Procedure by Gynecomastia Grade (Rohrich Classification) | Procedure | Bilateral measurement of the amount of skin excised during the procedure (if any) by Gynecomastia Grade (Rohrich Classification). Grade I (Minimal hypertrophy, \<250g of breast tissue, without ptosis) I A: Primarily glandular\* I B: Primarily fibrous\* Grade II (Moderate hypertrophy, 250-500g of breast tissue, without ptosis) I A: Primarily glandular\* I B: Primarily fibrous\* Grade III (Severe hypertrophy, \>500g of breast tissue, with grade I ptosis Glandular or fibrous\*) Grade IV (Severe hypertrophy with grade I or III ptosis) Glandular or fibrous\* \*Fatty and glandular tissue is determined by a pinch test medially, laterally, and beneath the nipple-areola complex |
| Gland Tissue Removal by Number of Participants | Procedure | Bilateral analysis of the number of subjects with gland tissue removed by the during the procedure. The technique utilized for subjects in this study was a mixed surgical technique. The Investigator removed progressive strips of gland in a radial fashion until optimal extraction by palpation was achieved. |
| Bilateral Analysis of Change to Soft-Tissue Pinch Thickness of the Upper Pole | Day 30, 90, 180 | A measurement of the soft-tissue pinch thickness of the upper pole, by isolating skin and subcutaneous tissue superior to the breast parenchyma, pinching firmly, and measuring the thickness with a caliper. |
| Bilateral Subject Global Aesthetic Improvement Scale | Day 30, 90, 180 | The subject will complete a bilateral Subject Global Aesthetic Improvement Scale assessing overall aesthetic improvement in the treatment area. Rating scale: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse |
| Bilateral Patient Satisfaction Questionnaire | Day 30, 90, 180 | The subject will complete a bilateral Patient Satisfaction Questionnaire for the evaluation of satisfaction for the right side and for the left side. Questions were Yes/No responses. |
| Correct Identification of Renuvion-treated Side by Blinded Independent Photographic Reviewers | Day 180 | Three experienced, blinded photographic reviewers performed a qualitative analysis/review of pre-treatment and post-treatment sets of images for each subject. Images were provided in a blinded and randomized order. Each blinded reviewer choose which side of the chest was treated with gynecomastia correction surgery followed by Renuvion treatment. Success was the correct identification of treated side of the chest by at least 2 of the 3 reviewers. |
| Bilateral Physician Global Aesthetic Improvement Scale | Day 30, 90, 180 | The Principal Investigator, sub-investigator or qualified clinician delegated by the principal investigator, will complete a bilateral Physician Global Aesthetic Improvement Scale assessing overall aesthetic improvement in the treatment area. Rating scale: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse |
Countries
United States
Participant flow
Recruitment details
Patients were recruited from a single site in the United States.
Pre-assignment details
All ten subjects in need of gynecomastia correction surgery were treated in a bilateral randomized design. One side of the chest received gynecomastia surgery. The other side received gynecomastia surgery followed by treatment with Renuvion.
Participants by arm
| Arm | Count |
|---|---|
| All Subjects Total of all reporting groups | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | All Subjects |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Age, Continuous | 41 years |
| BMI | 26.5 kg/m^2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Region of Enrollment United States | 10 participants |
| Rohrich Classification of Gynecomastia Grade IIA | 8 Participants |
| Rohrich Classification of Gynecomastia Grade IIB | 2 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 4 / 10 | 5 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
Analysis of Bilateral Occurrence of Adverse Events
Analysis of bilateral occurrence of adverse events by study arm.
Time frame: Through Day 180
Population: Healthy, male adult subjects, ages 18 - 75 years old who meet the inclusion/exclusion criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gynecomastia Surgery Followed by Renuvion | Analysis of Bilateral Occurrence of Adverse Events | Number of Expected Treatment Effects | 42 Number of Events |
| Gynecomastia Surgery Followed by Renuvion | Analysis of Bilateral Occurrence of Adverse Events | Number of Adverse Events | 6 Number of Events |
| Gynecomastia Surgery Only | Analysis of Bilateral Occurrence of Adverse Events | Number of Expected Treatment Effects | 38 Number of Events |
| Gynecomastia Surgery Only | Analysis of Bilateral Occurrence of Adverse Events | Number of Adverse Events | 7 Number of Events |
Secondary
Bilateral Analysis of Change to Soft-Tissue Pinch Thickness at the Inframammary Fold
A measurement of soft-tissue pinch thickness at the inframammary fold by isolating skin and subcutaneous tissue at the inframammary fold, pinching firmly, and measuring the thickness with a caliper.
Time frame: Day 30, 90, 180
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gynecomastia Surgery Followed by Renuvion | Bilateral Analysis of Change to Soft-Tissue Pinch Thickness at the Inframammary Fold | Change from Baseline to D180 | -0.17 cm | Standard Deviation 0.23 |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Analysis of Change to Soft-Tissue Pinch Thickness at the Inframammary Fold | Change from Baseline to D30 | -0.11 cm | Standard Deviation 0.022 |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Analysis of Change to Soft-Tissue Pinch Thickness at the Inframammary Fold | Change from Baseline to D90 | -0.16 cm | Standard Deviation 0.27 |
| Gynecomastia Surgery Only | Bilateral Analysis of Change to Soft-Tissue Pinch Thickness at the Inframammary Fold | Change from Baseline to D30 | -0.24 cm | Standard Deviation 0.29 |
| Gynecomastia Surgery Only | Bilateral Analysis of Change to Soft-Tissue Pinch Thickness at the Inframammary Fold | Change from Baseline to D90 | -0.28 cm | Standard Deviation 0.22 |
| Gynecomastia Surgery Only | Bilateral Analysis of Change to Soft-Tissue Pinch Thickness at the Inframammary Fold | Change from Baseline to D180 | -0.29 cm | Standard Deviation 0.26 |
Secondary
Bilateral Analysis of Change to Soft-Tissue Pinch Thickness of the Upper Pole
A measurement of the soft-tissue pinch thickness of the upper pole, by isolating skin and subcutaneous tissue superior to the breast parenchyma, pinching firmly, and measuring the thickness with a caliper.
Time frame: Day 30, 90, 180
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gynecomastia Surgery Followed by Renuvion | Bilateral Analysis of Change to Soft-Tissue Pinch Thickness of the Upper Pole | Change from Baseline to D30 | -0.29 cm | Standard Deviation 0.37 |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Analysis of Change to Soft-Tissue Pinch Thickness of the Upper Pole | Change from Baseline to D90 | -0.49 cm | Standard Deviation 0.51 |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Analysis of Change to Soft-Tissue Pinch Thickness of the Upper Pole | Change from Baseline to D180 | -0.59 cm | Standard Deviation 0.53 |
| Gynecomastia Surgery Only | Bilateral Analysis of Change to Soft-Tissue Pinch Thickness of the Upper Pole | Change from Baseline to D30 | -0.31 cm | Standard Deviation 0.52 |
| Gynecomastia Surgery Only | Bilateral Analysis of Change to Soft-Tissue Pinch Thickness of the Upper Pole | Change from Baseline to D90 | -0.59 cm | Standard Deviation 0.51 |
| Gynecomastia Surgery Only | Bilateral Analysis of Change to Soft-Tissue Pinch Thickness of the Upper Pole | Change from Baseline to D180 | -0.72 cm | Standard Deviation 0.5 |
Secondary
Bilateral Analysis of Male Chest Measurements
Measurement of suprasternal notch to nipple, inter-nipple distance, suprasternal notch to nipple plane, midclavicular point to nipple, nipple plane to umbilicus, umbilicus to pubic symphysis, coracoid process to nipple plane, nipple plane to medial epicondyle, and coracoid process to medial epicondyle.
Time frame: Day 30, 90, 180
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Gynecomastia Surgery Followed by Renuvion | Bilateral Analysis of Male Chest Measurements | Change in Nipple Plane to Umbilicus from Baseline to D90 | -0.4 cm |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Analysis of Male Chest Measurements | Change in Internipple Distance from Baseline to D30 | -0.4 cm |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Analysis of Male Chest Measurements | Change in Nipple Plane to Umbilicus from Baseline to D180 | -0.3 cm |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Analysis of Male Chest Measurements | Change in Suprasternal Notch to Nipple Plane from Baseline to D90 | -3.5 cm |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Analysis of Male Chest Measurements | Change in Umbilicus to Pubic Symphysis from Baseline to D30 | 0 cm |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Analysis of Male Chest Measurements | Change in Suprasternal Notch to Nipple from Baseline to D30 | -0.1 cm |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Analysis of Male Chest Measurements | Change in Umbilicus to Pubic Symphysis from Baseline to D90 | 0 cm |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Analysis of Male Chest Measurements | Change in Suprasternal Notch to Nipple Plane from Baseline to D180 | -3.4 cm |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Analysis of Male Chest Measurements | Change in Umbilicus to Pubic Symphysis from Baseline to D180 | 0 cm |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Analysis of Male Chest Measurements | Change in Internipple Distance from Baseline to D90 | -0.7 cm |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Analysis of Male Chest Measurements | Change in Coracoid Process to Nipple Plane from Baseline to D30 | 0.1 cm |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Analysis of Male Chest Measurements | Change in Midclavicular Point to Nipple from Baseline to D30 | 0.1 cm |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Analysis of Male Chest Measurements | Change in Coracoid Process to Nipple Plane from Baseline to D90 | 0.2 cm |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Analysis of Male Chest Measurements | Change in Suprasternal Notch to Nipple from Baseline to D180 | -0.3 cm |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Analysis of Male Chest Measurements | Change in Coracoid Process to Nipple Plane from Baseline to D180 | 0.1 cm |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Analysis of Male Chest Measurements | Change in Midclavicular Point to Nipple from Baseline to D90 | 0.2 cm |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Analysis of Male Chest Measurements | Change in Nipple Plane to Medial Epicondyle from Baseline to D30 | -0.1 cm |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Analysis of Male Chest Measurements | Change in Internipple Distance from Baseline to D180 | -0.8 cm |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Analysis of Male Chest Measurements | Change in Nipple Plane to Medial Epicondyle from Baseline to D90 | -0.2 cm |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Analysis of Male Chest Measurements | Change in Nipple Plane to Medial Epicondyle from Baseline to D180 | -0.2 cm |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Analysis of Male Chest Measurements | Change in Midclavicular Point to Nipple from Baseline to D180 | 0.1 cm |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Analysis of Male Chest Measurements | Change in Coracoid Process to Medial Epicondyle from Baseline to D30 | 0 cm |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Analysis of Male Chest Measurements | Change in Suprasternal Notch to Nipple from Baseline to D90 | -0.1 cm |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Analysis of Male Chest Measurements | Change in Coracoid Process to Medial Epicondyle from Baseline to D90 | 0 cm |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Analysis of Male Chest Measurements | Change in Nipple Plane to Umbilicus from Baseline to D30 | -0.4 cm |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Analysis of Male Chest Measurements | Change in Coracoid Process to Medial Epicondyle from Baseline to D180 | 0 cm |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Analysis of Male Chest Measurements | Change in Suprasternal Notch to Nipple Plane from Baseline to D30 | -1.8 cm |
| Gynecomastia Surgery Only | Bilateral Analysis of Male Chest Measurements | Change in Coracoid Process to Medial Epicondyle from Baseline to D180 | 0 cm |
| Gynecomastia Surgery Only | Bilateral Analysis of Male Chest Measurements | Change in Suprasternal Notch to Nipple from Baseline to D30 | 0 cm |
| Gynecomastia Surgery Only | Bilateral Analysis of Male Chest Measurements | Change in Suprasternal Notch to Nipple from Baseline to D90 | 0 cm |
| Gynecomastia Surgery Only | Bilateral Analysis of Male Chest Measurements | Change in Suprasternal Notch to Nipple from Baseline to D180 | -0.1 cm |
| Gynecomastia Surgery Only | Bilateral Analysis of Male Chest Measurements | Change in Internipple Distance from Baseline to D30 | -0.4 cm |
| Gynecomastia Surgery Only | Bilateral Analysis of Male Chest Measurements | Change in Internipple Distance from Baseline to D90 | -0.7 cm |
| Gynecomastia Surgery Only | Bilateral Analysis of Male Chest Measurements | Change in Internipple Distance from Baseline to D180 | -0.8 cm |
| Gynecomastia Surgery Only | Bilateral Analysis of Male Chest Measurements | Change in Suprasternal Notch to Nipple Plane from Baseline to D30 | -2.0 cm |
| Gynecomastia Surgery Only | Bilateral Analysis of Male Chest Measurements | Change in Suprasternal Notch to Nipple Plane from Baseline to D90 | -3.5 cm |
| Gynecomastia Surgery Only | Bilateral Analysis of Male Chest Measurements | Change in Suprasternal Notch to Nipple Plane from Baseline to D180 | -3.5 cm |
| Gynecomastia Surgery Only | Bilateral Analysis of Male Chest Measurements | Change in Midclavicular Point to Nipple from Baseline to D30 | 0 cm |
| Gynecomastia Surgery Only | Bilateral Analysis of Male Chest Measurements | Change in Midclavicular Point to Nipple from Baseline to D90 | 0.3 cm |
| Gynecomastia Surgery Only | Bilateral Analysis of Male Chest Measurements | Change in Midclavicular Point to Nipple from Baseline to D180 | 0.3 cm |
| Gynecomastia Surgery Only | Bilateral Analysis of Male Chest Measurements | Change in Nipple Plane to Umbilicus from Baseline to D30 | -0.4 cm |
| Gynecomastia Surgery Only | Bilateral Analysis of Male Chest Measurements | Change in Nipple Plane to Umbilicus from Baseline to D90 | -0.4 cm |
| Gynecomastia Surgery Only | Bilateral Analysis of Male Chest Measurements | Change in Nipple Plane to Umbilicus from Baseline to D180 | -0.3 cm |
| Gynecomastia Surgery Only | Bilateral Analysis of Male Chest Measurements | Change in Umbilicus to Pubic Symphysis from Baseline to D30 | 0 cm |
| Gynecomastia Surgery Only | Bilateral Analysis of Male Chest Measurements | Change in Umbilicus to Pubic Symphysis from Baseline to D90 | 0 cm |
| Gynecomastia Surgery Only | Bilateral Analysis of Male Chest Measurements | Change in Umbilicus to Pubic Symphysis from Baseline to D180 | 0 cm |
| Gynecomastia Surgery Only | Bilateral Analysis of Male Chest Measurements | Change in Coracoid Process to Nipple Plane from Baseline to D30 | -0.1 cm |
| Gynecomastia Surgery Only | Bilateral Analysis of Male Chest Measurements | Change in Coracoid Process to Nipple Plane from Baseline to D90 | 0.1 cm |
| Gynecomastia Surgery Only | Bilateral Analysis of Male Chest Measurements | Change in Coracoid Process to Nipple Plane from Baseline to D180 | 0.2 cm |
| Gynecomastia Surgery Only | Bilateral Analysis of Male Chest Measurements | Change in Nipple Plane to Medial Epicondyle from Baseline to D30 | -0.1 cm |
| Gynecomastia Surgery Only | Bilateral Analysis of Male Chest Measurements | Change in Nipple Plane to Medial Epicondyle from Baseline to D180 | -0.4 cm |
| Gynecomastia Surgery Only | Bilateral Analysis of Male Chest Measurements | Change in Coracoid Process to Medial Epicondyle from Baseline to D30 | 0 cm |
| Gynecomastia Surgery Only | Bilateral Analysis of Male Chest Measurements | Change in Coracoid Process to Medial Epicondyle from Baseline to D90 | 0 cm |
| Gynecomastia Surgery Only | Bilateral Analysis of Male Chest Measurements | Change in Nipple Plane to Medial Epicondyle from Baseline to D90 | -0.3 cm |
Secondary
Bilateral Analysis of the Amount of Skin Excised During the Procedure by Gynecomastia Grade (Rohrich Classification)
Bilateral measurement of the amount of skin excised during the procedure (if any) by Gynecomastia Grade (Rohrich Classification). Grade I (Minimal hypertrophy, \<250g of breast tissue, without ptosis) I A: Primarily glandular\* I B: Primarily fibrous\* Grade II (Moderate hypertrophy, 250-500g of breast tissue, without ptosis) I A: Primarily glandular\* I B: Primarily fibrous\* Grade III (Severe hypertrophy, \>500g of breast tissue, with grade I ptosis Glandular or fibrous\*) Grade IV (Severe hypertrophy with grade I or III ptosis) Glandular or fibrous\* \*Fatty and glandular tissue is determined by a pinch test medially, laterally, and beneath the nipple-areola complex
Time frame: Procedure
Population: None of the patients in this study had skin excised during treatment, thus none were analyzed for this endpoint which was looking at how much skin was excised by their Gynecomastia Grade. In the case of this study, it was none.
| Arm | Measure | Group | Value |
|---|---|---|---|
| Unknown | Bilateral Analysis of the Amount of Skin Excised During the Procedure by Gynecomastia Grade (Rohrich Classification) | Grade 1 | — |
| Unknown | Bilateral Analysis of the Amount of Skin Excised During the Procedure by Gynecomastia Grade (Rohrich Classification) | Grade II | — |
| Unknown | Bilateral Analysis of the Amount of Skin Excised During the Procedure by Gynecomastia Grade (Rohrich Classification) | Grade III | — |
| Unknown | Bilateral Analysis of the Amount of Skin Excised During the Procedure by Gynecomastia Grade (Rohrich Classification) | Grade IV | — |
Secondary
Bilateral Patient Satisfaction Questionnaire
The subject will complete a bilateral Patient Satisfaction Questionnaire for the evaluation of satisfaction for the right side and for the left side. Questions were Yes/No responses.
Time frame: Day 30, 90, 180
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gynecomastia Surgery Followed by Renuvion | Bilateral Patient Satisfaction Questionnaire | Noted improvement in skin texture in the treatment area | 6 Participants |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Patient Satisfaction Questionnaire | Believed this side side looked better | 3 Participants |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Patient Satisfaction Questionnaire | Noted more chest definition | 8 Participants |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Patient Satisfaction Questionnaire | Requested a balancing procedure | 7 Participants |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Patient Satisfaction Questionnaire | Noticed a difference in the sides of the chest | 9 Participants |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Patient Satisfaction Questionnaire | Would recommend the procedure to a friend | 9 Participants |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Patient Satisfaction Questionnaire | Happy with the results | 9 Participants |
| Gynecomastia Surgery Only | Bilateral Patient Satisfaction Questionnaire | Would recommend the procedure to a friend | 10 Participants |
| Gynecomastia Surgery Only | Bilateral Patient Satisfaction Questionnaire | Happy with the results | 10 Participants |
| Gynecomastia Surgery Only | Bilateral Patient Satisfaction Questionnaire | Noted more chest definition | 8 Participants |
| Gynecomastia Surgery Only | Bilateral Patient Satisfaction Questionnaire | Noted improvement in skin texture in the treatment area | 5 Participants |
| Gynecomastia Surgery Only | Bilateral Patient Satisfaction Questionnaire | Noticed a difference in the sides of the chest | 9 Participants |
| Gynecomastia Surgery Only | Bilateral Patient Satisfaction Questionnaire | Believed this side side looked better | 6 Participants |
| Gynecomastia Surgery Only | Bilateral Patient Satisfaction Questionnaire | Requested a balancing procedure | 7 Participants |
Secondary
Bilateral Physician Global Aesthetic Improvement Scale
The Principal Investigator, sub-investigator or qualified clinician delegated by the principal investigator, will complete a bilateral Physician Global Aesthetic Improvement Scale assessing overall aesthetic improvement in the treatment area. Rating scale: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse
Time frame: Day 30, 90, 180
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Gynecomastia Surgery Followed by Renuvion | Bilateral Physician Global Aesthetic Improvement Scale | D30 | Very Much Improved | 2 Participants |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Physician Global Aesthetic Improvement Scale | D30 | Much Improved | 5 Participants |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Physician Global Aesthetic Improvement Scale | D30 | Improved | 2 Participants |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Physician Global Aesthetic Improvement Scale | D30 | No Change | 1 Participants |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Physician Global Aesthetic Improvement Scale | D30 | Worse | 0 Participants |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Physician Global Aesthetic Improvement Scale | D30 | Much Worse | 0 Participants |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Physician Global Aesthetic Improvement Scale | D30 | Very Much Worse | 0 Participants |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Physician Global Aesthetic Improvement Scale | D90 | Very Much Improved | 6 Participants |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Physician Global Aesthetic Improvement Scale | D90 | Much Improved | 2 Participants |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Physician Global Aesthetic Improvement Scale | D90 | Improved | 2 Participants |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Physician Global Aesthetic Improvement Scale | D90 | No Change | 0 Participants |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Physician Global Aesthetic Improvement Scale | D90 | Worse | 0 Participants |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Physician Global Aesthetic Improvement Scale | D90 | Much Worse | 0 Participants |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Physician Global Aesthetic Improvement Scale | D90 | Very Much Worse | 0 Participants |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Physician Global Aesthetic Improvement Scale | D180 | Very Much Improved | 6 Participants |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Physician Global Aesthetic Improvement Scale | D180 | Much Improved | 4 Participants |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Physician Global Aesthetic Improvement Scale | D180 | Improved | 0 Participants |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Physician Global Aesthetic Improvement Scale | D180 | No Change | 0 Participants |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Physician Global Aesthetic Improvement Scale | D180 | Worse | 0 Participants |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Physician Global Aesthetic Improvement Scale | D180 | Much Worse | 0 Participants |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Physician Global Aesthetic Improvement Scale | D180 | Very Much Worse | 0 Participants |
| Gynecomastia Surgery Only | Bilateral Physician Global Aesthetic Improvement Scale | D90 | No Change | 0 Participants |
| Gynecomastia Surgery Only | Bilateral Physician Global Aesthetic Improvement Scale | D30 | Very Much Improved | 2 Participants |
| Gynecomastia Surgery Only | Bilateral Physician Global Aesthetic Improvement Scale | D180 | Worse | 0 Participants |
| Gynecomastia Surgery Only | Bilateral Physician Global Aesthetic Improvement Scale | D30 | Much Improved | 4 Participants |
| Gynecomastia Surgery Only | Bilateral Physician Global Aesthetic Improvement Scale | D90 | Worse | 0 Participants |
| Gynecomastia Surgery Only | Bilateral Physician Global Aesthetic Improvement Scale | D30 | Improved | 4 Participants |
| Gynecomastia Surgery Only | Bilateral Physician Global Aesthetic Improvement Scale | D180 | Improved | 1 Participants |
| Gynecomastia Surgery Only | Bilateral Physician Global Aesthetic Improvement Scale | D30 | No Change | 0 Participants |
| Gynecomastia Surgery Only | Bilateral Physician Global Aesthetic Improvement Scale | D90 | Much Worse | 0 Participants |
| Gynecomastia Surgery Only | Bilateral Physician Global Aesthetic Improvement Scale | D30 | Worse | 0 Participants |
| Gynecomastia Surgery Only | Bilateral Physician Global Aesthetic Improvement Scale | D180 | Very Much Worse | 0 Participants |
| Gynecomastia Surgery Only | Bilateral Physician Global Aesthetic Improvement Scale | D30 | Much Worse | 0 Participants |
| Gynecomastia Surgery Only | Bilateral Physician Global Aesthetic Improvement Scale | D90 | Very Much Worse | 0 Participants |
| Gynecomastia Surgery Only | Bilateral Physician Global Aesthetic Improvement Scale | D30 | Very Much Worse | 0 Participants |
| Gynecomastia Surgery Only | Bilateral Physician Global Aesthetic Improvement Scale | D180 | No Change | 0 Participants |
| Gynecomastia Surgery Only | Bilateral Physician Global Aesthetic Improvement Scale | D90 | Very Much Improved | 2 Participants |
| Gynecomastia Surgery Only | Bilateral Physician Global Aesthetic Improvement Scale | D180 | Very Much Improved | 6 Participants |
| Gynecomastia Surgery Only | Bilateral Physician Global Aesthetic Improvement Scale | D90 | Much Improved | 7 Participants |
| Gynecomastia Surgery Only | Bilateral Physician Global Aesthetic Improvement Scale | D180 | Much Worse | 0 Participants |
| Gynecomastia Surgery Only | Bilateral Physician Global Aesthetic Improvement Scale | D90 | Improved | 1 Participants |
| Gynecomastia Surgery Only | Bilateral Physician Global Aesthetic Improvement Scale | D180 | Much Improved | 3 Participants |
Secondary
Bilateral Subject Global Aesthetic Improvement Scale
The subject will complete a bilateral Subject Global Aesthetic Improvement Scale assessing overall aesthetic improvement in the treatment area. Rating scale: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse
Time frame: Day 30, 90, 180
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Gynecomastia Surgery Followed by Renuvion | Bilateral Subject Global Aesthetic Improvement Scale | D30 | Very Much Improved | 4 Participants |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Subject Global Aesthetic Improvement Scale | D30 | Much Improved | 4 Participants |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Subject Global Aesthetic Improvement Scale | D30 | Improved | 2 Participants |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Subject Global Aesthetic Improvement Scale | D30 | No Change | 0 Participants |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Subject Global Aesthetic Improvement Scale | D30 | Worse | 0 Participants |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Subject Global Aesthetic Improvement Scale | D30 | Much Worse | 0 Participants |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Subject Global Aesthetic Improvement Scale | D30 | Very Much Worse | 0 Participants |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Subject Global Aesthetic Improvement Scale | D90 | Very Much Improved | 4 Participants |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Subject Global Aesthetic Improvement Scale | D90 | Much Improved | 5 Participants |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Subject Global Aesthetic Improvement Scale | D90 | Improved | 1 Participants |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Subject Global Aesthetic Improvement Scale | D90 | No Change | 0 Participants |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Subject Global Aesthetic Improvement Scale | D90 | Worse | 0 Participants |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Subject Global Aesthetic Improvement Scale | D90 | Much Worse | 0 Participants |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Subject Global Aesthetic Improvement Scale | D90 | Very Much Worse | 0 Participants |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Subject Global Aesthetic Improvement Scale | D180 | Very Much Improved | 5 Participants |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Subject Global Aesthetic Improvement Scale | D180 | Much Improved | 3 Participants |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Subject Global Aesthetic Improvement Scale | D180 | Improved | 2 Participants |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Subject Global Aesthetic Improvement Scale | D180 | No Change | 0 Participants |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Subject Global Aesthetic Improvement Scale | D180 | Worse | 0 Participants |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Subject Global Aesthetic Improvement Scale | D180 | Much Worse | 0 Participants |
| Gynecomastia Surgery Followed by Renuvion | Bilateral Subject Global Aesthetic Improvement Scale | D180 | Very Much Worse | 0 Participants |
| Gynecomastia Surgery Only | Bilateral Subject Global Aesthetic Improvement Scale | D90 | No Change | 0 Participants |
| Gynecomastia Surgery Only | Bilateral Subject Global Aesthetic Improvement Scale | D30 | Very Much Improved | 3 Participants |
| Gynecomastia Surgery Only | Bilateral Subject Global Aesthetic Improvement Scale | D180 | Worse | 0 Participants |
| Gynecomastia Surgery Only | Bilateral Subject Global Aesthetic Improvement Scale | D30 | Much Improved | 4 Participants |
| Gynecomastia Surgery Only | Bilateral Subject Global Aesthetic Improvement Scale | D90 | Worse | 0 Participants |
| Gynecomastia Surgery Only | Bilateral Subject Global Aesthetic Improvement Scale | D30 | Improved | 3 Participants |
| Gynecomastia Surgery Only | Bilateral Subject Global Aesthetic Improvement Scale | D180 | Improved | 1 Participants |
| Gynecomastia Surgery Only | Bilateral Subject Global Aesthetic Improvement Scale | D30 | No Change | 0 Participants |
| Gynecomastia Surgery Only | Bilateral Subject Global Aesthetic Improvement Scale | D90 | Much Worse | 0 Participants |
| Gynecomastia Surgery Only | Bilateral Subject Global Aesthetic Improvement Scale | D30 | Worse | 0 Participants |
| Gynecomastia Surgery Only | Bilateral Subject Global Aesthetic Improvement Scale | D180 | Very Much Worse | 0 Participants |
| Gynecomastia Surgery Only | Bilateral Subject Global Aesthetic Improvement Scale | D30 | Much Worse | 0 Participants |
| Gynecomastia Surgery Only | Bilateral Subject Global Aesthetic Improvement Scale | D90 | Very Much Worse | 0 Participants |
| Gynecomastia Surgery Only | Bilateral Subject Global Aesthetic Improvement Scale | D30 | Very Much Worse | 0 Participants |
| Gynecomastia Surgery Only | Bilateral Subject Global Aesthetic Improvement Scale | D180 | No Change | 0 Participants |
| Gynecomastia Surgery Only | Bilateral Subject Global Aesthetic Improvement Scale | D90 | Very Much Improved | 5 Participants |
| Gynecomastia Surgery Only | Bilateral Subject Global Aesthetic Improvement Scale | D180 | Very Much Improved | 5 Participants |
| Gynecomastia Surgery Only | Bilateral Subject Global Aesthetic Improvement Scale | D90 | Much Improved | 5 Participants |
| Gynecomastia Surgery Only | Bilateral Subject Global Aesthetic Improvement Scale | D180 | Much Worse | 0 Participants |
| Gynecomastia Surgery Only | Bilateral Subject Global Aesthetic Improvement Scale | D90 | Improved | 0 Participants |
| Gynecomastia Surgery Only | Bilateral Subject Global Aesthetic Improvement Scale | D180 | Much Improved | 4 Participants |
Secondary
Correct Identification of Renuvion-treated Side by Blinded Independent Photographic Reviewers
Three experienced, blinded photographic reviewers performed a qualitative analysis/review of pre-treatment and post-treatment sets of images for each subject. Images were provided in a blinded and randomized order. Each blinded reviewer choose which side of the chest was treated with gynecomastia correction surgery followed by Renuvion treatment. Success was the correct identification of treated side of the chest by at least 2 of the 3 reviewers.
Time frame: Day 180
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gynecomastia Surgery Followed by Renuvion | Correct Identification of Renuvion-treated Side by Blinded Independent Photographic Reviewers | 5 Correctly identified side. |
Secondary
Gland Tissue Removal by Number of Participants
Bilateral analysis of the number of subjects with gland tissue removed by the during the procedure. The technique utilized for subjects in this study was a mixed surgical technique. The Investigator removed progressive strips of gland in a radial fashion until optimal extraction by palpation was achieved.
Time frame: Procedure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gynecomastia Surgery Followed by Renuvion | Gland Tissue Removal by Number of Participants | No Excision | 8 participants |
| Gynecomastia Surgery Followed by Renuvion | Gland Tissue Removal by Number of Participants | Excision | 2 participants |
| Gynecomastia Surgery Only | Gland Tissue Removal by Number of Participants | No Excision | 8 participants |
| Gynecomastia Surgery Only | Gland Tissue Removal by Number of Participants | Excision | 2 participants |