Breast Ptosis
Conditions
Brief summary
This is a prospective, non-randomized, single-center, evaluator blinded study of up to 15 subjects undergoing a minimally invasive breast lift procedure utilizing the Renuvion APR System. Subjects will receive treatment with the Renuvion APR System to both breasts.
Detailed description
This is a prospective, non-randomized, single-center, evaluator blinded study of up to 15 subjects undergoing a minimally invasive breast lift procedure utilizing the Renuvion APR System. Subjects will receive treatment with the Renuvion APR System to both breasts. At baseline, the grade of breast ptosis, breast measurements and pre-surgery photographs will be taken using the site's camera system. Procedure data and adverse events will be captured. Follow-up visits will occur at 30, 90, and 180-days post-procedure. Subjects may also be seen back for follow-up at the investigator's discretion.
Interventions
DEVICERenuvion APR System
The treatment area is defined as superior most not to exceed a horizontal line from the superior aspect of the axilla to the midline; inferior most not to cross the junction of the breast with the abdomen (inframammary fold). Lateral border to the outermost curvature of the breast or a vertical line drawn from the preaxillary line to the IMF; medial most to the innermost curvature of the breast up to 1 cm lateral to the sternal midline. The procedure will be in the intradermal and subdermal planes in the full breast area, without penetrating the breast gland. Renuvion APR System settings will be 60-70% Power, 1.5 LPM, and up to 6 retrograde or 3 antegrade/retrograde passes, with a minimum of 2 incision sites.
Sponsors
Apyx Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Female subjects, ages 18 - 75 years old. * ASA Physical Status Classification System Class I and Class II subjects. * Breast Ptosis Class II and Class III as per the Eyck et al, Rainbow Scale for Assessing Breast Ptosis. * Breast Cup Size A and Size B. * Understands and accepts the obligation not to undergo any other procedures or treatments in the areas to be treated during study participation. * Absence of physical conditions unacceptable to the investigator. * Females of childbearing potential who are sexually active must be willing to use an approved method of birth control during study participation. * Willing and able to comply with protocol requirements, including study-required images/photos, assessments/measurements, and returning for follow-up visits. * Willing to release rights for the use of study photos, including in publication. * Able to read, understand, sign, and date the informed consent. * Able to communicate with the site via video and/or photographs, in the event of a virtual follow-up visit.
Exclusion criteria
* Subjects presenting with ASA Physical Status Classification System Classes III or higher. * Breast ptosis Class IV or more as per the Eyck et al, Rainbow Scale for Assessing Breast Ptosis. * Breast Cup Size C, Size D or larger. * Prior surgery or procedure in the breast area (i.e., implants, skin tightening procedures, breast reduction, etc.). * Pregnant, lactating, or plans to become pregnant during study participation. * Known hypersensitivity or allergy to tumescent anesthetic (lidocaine/ epinephrine). * Known hypersensitivity or allergy to ibuprofen or other NSAIDS. * Previous treatment in the study treatment area. * Active systemic or local skin disease that may alter wound healing. * Significant or uncontrolled medical condition that in the opinion of the investigator participation in the study may compromise the patient's health. * History of autoimmune disease (excluding Hashimoto's thyroiditis). * Known susceptibility to keloid formation or hypertrophic scarring. * Cancerous or pre-cancerous lesions in the area to be treated. * Possesses a surgically implanted electronic device (i.e., pacemaker). * Serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in the past two years. * Participation in any other investigational study within 30 days prior to consent and throughout study participation. * Subject who, in the opinion of the investigator, is not an appropriate candidate for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Independent Photographic Review of Before and After Images Compared to Baseline Compared to D180. | 180-Day | Improvement in breast ptosis as determined by a masked, qualitative assessment of photographs at 180-days post-treatment compared to baseline by blinded independent reviewers. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Independent Photographic Review of Before and After Images Compared to Baseline at D90. | 90-Day | Improvement in breast ptosis as determined by a masked, qualitative assessment of photographs at 90-days post-treatment compared to baseline by blinded independent reviewers. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Morphometric Breast Measurements at Day 180 | 180-Day | Bilateral analysis of change to Morphometric breast measurements as per Brown, An Analysis of Ptosis at baseline and at D180. |
| Change in Breast Ptosis Classification at Day 180 | 180-Day | Evaluation by the investigator grading the amount of visual breast ptosis (breast laxity) by the Rainbow scale of ptosis includes 5 grades: a Grade I (no ptosis), Grade II (minimal ptosis), Grade III (moderate ptosis), Grade IV (more than moderate ptosis), V (severe ptosis) scale. |
| Investigator Global Aesthetic Improvement Scale (GAIS) at Day 30 | 30-Day | The investigator will grade the overall improvement of treatment area as very much improved, much improved, improved, no change, worse, much worse, or very much worse. |
| Investigator Global Aesthetic Improvement Scale (GAIS) at Day 90 | 90-Day | The investigator will grade the overall improvement of treatment area as very much improved, much improved, improved, no change, worse, much worse, or very much worse. |
| Investigator Global Aesthetic Improvement Scale (GAIS) at Day 180 | 180-Day | The investigator will grade the overall improvement of treatment area as very much improved, much improved, improved, no change, worse, much worse, or very much worse. |
| Subject Global Aesthetic Improvement Scale (GAIS) at Day 30 | 30-Day | The Subject will grade overall improvement of treatment area as very much improved, much improved, improved, no change, worse, much worse, or very much worse. |
| Subject Global Aesthetic Improvement Scale (GAIS) at Day 90 | 90-Day | The Subject will grade overall improvement of treatment area as very much improved, much improved, improved, no change, worse, much worse, or very much worse. |
| Change in Morphometric Breast Measurements at Day 30 | 30-Day | Bilateral analysis of change to Morphometric breast measurements as per Brown, An Analysis of Ptosis at baseline and at D30. |
| Patient Satisfaction Questionnaire (PSQ) at Day 180 | 180-Day | Subjects will be asked to complete a satisfaction survey referring to the assessment of baseline photos, current photos, and a mirror. Yes/No - Did you notice any improvement in the laxity or sagginess of your breasts? If yes, checkbox - Less sagging, Breasts look higher on the chest, Nipple placement is improved, Breasts appear more youthful, and/or Other. How would you characterize your satisfaction with the treatment? - very satisfied, satisfied, slightly satisfied, neither satisfied or dissatisfied, slightly dissatisfied, dissatisfied, very dissatisfied. Yes/No - Would you recommend this treatment to your friends and family members? |
| Breast-Q Survey | 180-Day | Subjects will complete the Psychosocial Well-Being and Sexual Well-Being questionnaires. Subjects were instructed With your breasts in mind, in the past week, how often have you felt:. Responses were 5 options: 1 - None of the time, 2 - A little of the time, 3 - Some of the time, 4 - Most of the time, 5 - All of the time. |
| Average Reported by Subject at Procedure | Procedure Day 0 (within 60 minutes following treatment) | Study subjects will be asked to complete a 11-point Numeric Rating Scale (NRS) for the level of pain and discomfort associated with the study procedure. Rating Scale where 0 is No Pain and 10 is Worst Possible Pain |
| Average Reported Pain by Subject at Day 30 | 30-Day | Study subjects will be asked to complete a 11-point Numeric Rating Scale (NRS) for the level of pain and discomfort associated with the study procedure. Rating Scale where 0 is No Pain and 10 is Worst Possible Pain |
| Average Reported Pain by Subject at Day 90 | 90-Day | Study subjects will be asked to complete a 11-point Numeric Rating Scale (NRS) for the level of pain and discomfort associated with the study procedure. Rating Scale where 0 is No Pain and 10 is Worst Possible Pain |
| Average Reported Pain by Subject at Day 180 | 180-Day | Study subjects will be asked to complete a 11-point Numeric Rating Scale (NRS) for the level of pain and discomfort associated with the study procedure. Rating Scale where 0 is No Pain and 10 is Worst Possible Pain |
| Subject Global Aesthetic Improvement Scale (GAIS) at Day 180 | 180-Day | The Subject will grade overall improvement of treatment area as very much improved, much improved, improved, no change, worse, much worse, or very much worse. |
| Change in Morphometric Breast Measurements at Day 90 | 90-Day | Bilateral analysis of change to Morphometric breast measurements as per Brown, An Analysis of Ptosis at baseline and at D90. |
Countries
Greece
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Renuvion APR System Subjects treated with the Renuvion APR system in both breasts.
Renuvion APR System: The treatment area is defined as superior most not to exceed a horizontal line from the superior aspect of the axilla to the midline; inferior most not to cross the junction of the breast with the abdomen (inframammary fold). Lateral border to the outermost curvature of the breast or a vertical line drawn from the preaxillary line to the IMF; medial most to the innermost curvature of the breast up to 1 cm lateral to the sternal midline. The procedure will be in the intradermal and subdermal planes in the full breast area, without penetrating the breast gland.
Renuvion APR System settings will be 60-70% Power, 1.5 LPM, and up to 6 retrograde or 3 antegrade/retrograde passes, with a minimum of 2 incision sites. | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | Renuvion APR System |
|---|---|
| Age, Continuous | 38 Years STANDARD_DEVIATION 9.1 |
| ASA Status ASA I | 13 Participants |
| ASA Status ASA II | 2 Participants |
| Average Reported Pain by Subject 0 | 15 Participants |
| Average Reported Pain by Subject 1 | 0 Participants |
| Average Reported Pain by Subject 10 | 0 Participants |
| Average Reported Pain by Subject 2 | 0 Participants |
| Average Reported Pain by Subject 3 | 0 Participants |
| Average Reported Pain by Subject 4 | 0 Participants |
| Average Reported Pain by Subject 5 | 0 Participants |
| Average Reported Pain by Subject 6 | 0 Participants |
| Average Reported Pain by Subject 7 | 0 Participants |
| Average Reported Pain by Subject 8 | 0 Participants |
| Average Reported Pain by Subject 9 | 0 Participants |
| Breast Cup Size Cup Size A | 2 Participants |
| Breast Cup Size Cup Size B | 13 Participants |
| Breast-Q Survey Accepting of your body? | 3.2 Average units on a scale STANDARD_DEVIATION 0.8 |
| Breast-Q Survey Attractive? | 3.2 Average units on a scale STANDARD_DEVIATION 0.7 |
| Breast-Q Survey Comfortable/at ease during sexual activity? | 3.4 Average units on a scale STANDARD_DEVIATION 0.8 |
| Breast-Q Survey Confident about your body? | 3.0 Average units on a scale STANDARD_DEVIATION 0.5 |
| Breast-Q Survey Confident in a social setting? | 3.4 Average units on a scale STANDARD_DEVIATION 0.9 |
| Breast-Q Survey Confident in your clothes? | 3.1 Average units on a scale STANDARD_DEVIATION 0.6 |
| Breast-Q Survey Confident sexually? | 3.2 Average units on a scale STANDARD_DEVIATION 0.7 |
| Breast-Q Survey Confident sexually about how your breasts look when unclothed? | 2.3 Average units on a scale STANDARD_DEVIATION 0.5 |
| Breast-Q Survey Good about yourself? | 3.6 Average units on a scale STANDARD_DEVIATION 0.7 |
| Breast-Q Survey Of equal worth to other women? | 3.2 Average units on a scale STANDARD_DEVIATION 0.9 |
| Breast-Q Survey Self-assured? | 3.7 Average units on a scale STANDARD_DEVIATION 0.6 |
| Breast-Q Survey Self-confident? | 3.9 Average units on a scale STANDARD_DEVIATION 0.4 |
| Breast-Q Survey Sexually attractive in your clothes? | 3.1 Average units on a scale STANDARD_DEVIATION 0.7 |
| Breast-Q Survey Sexy when unclothed? | 2.5 Average units on a scale STANDARD_DEVIATION 0.6 |
| Race/Ethnicity, Customized Nationality Albanian | 1 Participants |
| Race/Ethnicity, Customized Nationality Brazilian | 2 Participants |
| Race/Ethnicity, Customized Nationality Greek | 12 Participants |
| Rainbow Scale for Breast Ptosis Grade I | 0 Participants |
| Rainbow Scale for Breast Ptosis Grade II | 15 Participants |
| Rainbow Scale for Breast Ptosis Grade III | 0 Participants |
| Rainbow Scale for Breast Ptosis Grade IV | 0 Participants |
| Rainbow Scale for Breast Ptosis Grade V | 0 Participants |
| Region of Enrollment Greece | 15 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
Primary
Independent Photographic Review of Before and After Images Compared to Baseline Compared to D180.
Improvement in breast ptosis as determined by a masked, qualitative assessment of photographs at 180-days post-treatment compared to baseline by blinded independent reviewers.
Time frame: 180-Day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Renuvion APR System | Independent Photographic Review of Before and After Images Compared to Baseline Compared to D180. | 11 Participants |
Secondary
Independent Photographic Review of Before and After Images Compared to Baseline at D90.
Improvement in breast ptosis as determined by a masked, qualitative assessment of photographs at 90-days post-treatment compared to baseline by blinded independent reviewers.
Time frame: 90-Day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Renuvion APR System | Independent Photographic Review of Before and After Images Compared to Baseline at D90. | 10 Participants |
Other Pre-specified
Average Reported by Subject at Procedure
Study subjects will be asked to complete a 11-point Numeric Rating Scale (NRS) for the level of pain and discomfort associated with the study procedure. Rating Scale where 0 is No Pain and 10 is Worst Possible Pain
Time frame: Procedure Day 0 (within 60 minutes following treatment)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Renuvion APR System | Average Reported by Subject at Procedure | 0 | 15 Participants |
| Renuvion APR System | Average Reported by Subject at Procedure | 1 | 0 Participants |
| Renuvion APR System | Average Reported by Subject at Procedure | 2 | 0 Participants |
| Renuvion APR System | Average Reported by Subject at Procedure | 3 | 0 Participants |
| Renuvion APR System | Average Reported by Subject at Procedure | 4 | 0 Participants |
| Renuvion APR System | Average Reported by Subject at Procedure | 5 | 0 Participants |
| Renuvion APR System | Average Reported by Subject at Procedure | 6 | 0 Participants |
| Renuvion APR System | Average Reported by Subject at Procedure | 7 | 0 Participants |
| Renuvion APR System | Average Reported by Subject at Procedure | 8 | 0 Participants |
| Renuvion APR System | Average Reported by Subject at Procedure | 9 | 0 Participants |
| Renuvion APR System | Average Reported by Subject at Procedure | 10 | 0 Participants |
Other Pre-specified
Average Reported Pain by Subject at Day 180
Study subjects will be asked to complete a 11-point Numeric Rating Scale (NRS) for the level of pain and discomfort associated with the study procedure. Rating Scale where 0 is No Pain and 10 is Worst Possible Pain
Time frame: 180-Day
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Renuvion APR System | Average Reported Pain by Subject at Day 180 | 4 | 0 Participants |
| Renuvion APR System | Average Reported Pain by Subject at Day 180 | 5 | 0 Participants |
| Renuvion APR System | Average Reported Pain by Subject at Day 180 | 8 | 0 Participants |
| Renuvion APR System | Average Reported Pain by Subject at Day 180 | 9 | 0 Participants |
| Renuvion APR System | Average Reported Pain by Subject at Day 180 | 0 | 15 Participants |
| Renuvion APR System | Average Reported Pain by Subject at Day 180 | 1 | 0 Participants |
| Renuvion APR System | Average Reported Pain by Subject at Day 180 | 2 | 0 Participants |
| Renuvion APR System | Average Reported Pain by Subject at Day 180 | 3 | 0 Participants |
| Renuvion APR System | Average Reported Pain by Subject at Day 180 | 6 | 0 Participants |
| Renuvion APR System | Average Reported Pain by Subject at Day 180 | 7 | 0 Participants |
| Renuvion APR System | Average Reported Pain by Subject at Day 180 | 10 | 0 Participants |
Other Pre-specified
Average Reported Pain by Subject at Day 30
Study subjects will be asked to complete a 11-point Numeric Rating Scale (NRS) for the level of pain and discomfort associated with the study procedure. Rating Scale where 0 is No Pain and 10 is Worst Possible Pain
Time frame: 30-Day
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Renuvion APR System | Average Reported Pain by Subject at Day 30 | 10 | 0 Participants |
| Renuvion APR System | Average Reported Pain by Subject at Day 30 | 0 | 15 Participants |
| Renuvion APR System | Average Reported Pain by Subject at Day 30 | 1 | 0 Participants |
| Renuvion APR System | Average Reported Pain by Subject at Day 30 | 2 | 0 Participants |
| Renuvion APR System | Average Reported Pain by Subject at Day 30 | 3 | 0 Participants |
| Renuvion APR System | Average Reported Pain by Subject at Day 30 | 4 | 0 Participants |
| Renuvion APR System | Average Reported Pain by Subject at Day 30 | 5 | 0 Participants |
| Renuvion APR System | Average Reported Pain by Subject at Day 30 | 6 | 0 Participants |
| Renuvion APR System | Average Reported Pain by Subject at Day 30 | 7 | 0 Participants |
| Renuvion APR System | Average Reported Pain by Subject at Day 30 | 8 | 0 Participants |
| Renuvion APR System | Average Reported Pain by Subject at Day 30 | 9 | 0 Participants |
Other Pre-specified
Average Reported Pain by Subject at Day 90
Study subjects will be asked to complete a 11-point Numeric Rating Scale (NRS) for the level of pain and discomfort associated with the study procedure. Rating Scale where 0 is No Pain and 10 is Worst Possible Pain
Time frame: 90-Day
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Renuvion APR System | Average Reported Pain by Subject at Day 90 | 0 | 15 Participants |
| Renuvion APR System | Average Reported Pain by Subject at Day 90 | 1 | 0 Participants |
| Renuvion APR System | Average Reported Pain by Subject at Day 90 | 2 | 0 Participants |
| Renuvion APR System | Average Reported Pain by Subject at Day 90 | 3 | 0 Participants |
| Renuvion APR System | Average Reported Pain by Subject at Day 90 | 4 | 0 Participants |
| Renuvion APR System | Average Reported Pain by Subject at Day 90 | 5 | 0 Participants |
| Renuvion APR System | Average Reported Pain by Subject at Day 90 | 6 | 0 Participants |
| Renuvion APR System | Average Reported Pain by Subject at Day 90 | 7 | 0 Participants |
| Renuvion APR System | Average Reported Pain by Subject at Day 90 | 8 | 0 Participants |
| Renuvion APR System | Average Reported Pain by Subject at Day 90 | 9 | 0 Participants |
| Renuvion APR System | Average Reported Pain by Subject at Day 90 | 10 | 0 Participants |
Other Pre-specified
Breast-Q Survey
Subjects will complete the Psychosocial Well-Being and Sexual Well-Being questionnaires. Subjects were instructed With your breasts in mind, in the past week, how often have you felt:. Responses were 5 options: 1 - None of the time, 2 - A little of the time, 3 - Some of the time, 4 - Most of the time, 5 - All of the time.
Time frame: 180-Day
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Renuvion APR System | Breast-Q Survey | Good about yourself? | 4.5 average units on a scale | Standard Deviation 0.5 |
| Renuvion APR System | Breast-Q Survey | Confident about your body? | 4.5 average units on a scale | Standard Deviation 0.5 |
| Renuvion APR System | Breast-Q Survey | Confident sexually? | 4.3 average units on a scale | Standard Deviation 0.5 |
| Renuvion APR System | Breast-Q Survey | Confident in a social setting? | 4.3 average units on a scale | Standard Deviation 0.5 |
| Renuvion APR System | Breast-Q Survey | Confident in your clothes? | 4.5 average units on a scale | Standard Deviation 0.5 |
| Renuvion APR System | Breast-Q Survey | Of equal worth to other women? | 4.3 average units on a scale | Standard Deviation 0.5 |
| Renuvion APR System | Breast-Q Survey | Attractive? | 4.2 average units on a scale | Standard Deviation 0.6 |
| Renuvion APR System | Breast-Q Survey | Accepting of your body? | 4.4 average units on a scale | Standard Deviation 0.6 |
| Renuvion APR System | Breast-Q Survey | Self-assured? | 4.4 average units on a scale | Standard Deviation 0.5 |
| Renuvion APR System | Breast-Q Survey | Self-confident? | 4.7 average units on a scale | Standard Deviation 0.5 |
| Renuvion APR System | Breast-Q Survey | Sexually attractive in your clothes? | 4.2 average units on a scale | Standard Deviation 0.6 |
| Renuvion APR System | Breast-Q Survey | Comfortable/at ease during sexual activity? | 4.3 average units on a scale | Standard Deviation 0.6 |
| Renuvion APR System | Breast-Q Survey | Sexy when unclothed? | 4.4 average units on a scale | Standard Deviation 0.6 |
| Renuvion APR System | Breast-Q Survey | Confident sexually about how your breasts look when unclothed? | 4.2 average units on a scale | Standard Deviation 0.6 |
Other Pre-specified
Change in Breast Ptosis Classification at Day 180
Evaluation by the investigator grading the amount of visual breast ptosis (breast laxity) by the Rainbow scale of ptosis includes 5 grades: a Grade I (no ptosis), Grade II (minimal ptosis), Grade III (moderate ptosis), Grade IV (more than moderate ptosis), V (severe ptosis) scale.
Time frame: 180-Day
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Renuvion APR System | Change in Breast Ptosis Classification at Day 180 | Grade V | 0 Participants |
| Renuvion APR System | Change in Breast Ptosis Classification at Day 180 | Grade III | 0 Participants |
| Renuvion APR System | Change in Breast Ptosis Classification at Day 180 | Grade IV | 0 Participants |
| Renuvion APR System | Change in Breast Ptosis Classification at Day 180 | Grade I | 6 Participants |
| Renuvion APR System | Change in Breast Ptosis Classification at Day 180 | Grade II | 9 Participants |
Other Pre-specified
Change in Morphometric Breast Measurements at Day 180
Bilateral analysis of change to Morphometric breast measurements as per Brown, An Analysis of Ptosis at baseline and at D180.
Time frame: 180-Day
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Renuvion APR System | Change in Morphometric Breast Measurements at Day 180 | MCL-N: measurement taken from the mid clavicle to the mid nipple | -0.9 cm change from baseline | Standard Deviation 0.7 |
| Renuvion APR System | Change in Morphometric Breast Measurements at Day 180 | SNN-N: measurements taken at the mid nipple diameter on both sides | -1.2 cm change from baseline | Standard Deviation 0.7 |
| Renuvion APR System | Change in Morphometric Breast Measurements at Day 180 | IMC-N: measurement taken from the base of the breast to the base of the nipple | -0.6 cm change from baseline | Standard Deviation 0.5 |
| Renuvion APR System | Change in Morphometric Breast Measurements at Day 180 | NAC: nipple-areola complex diameter | 0.1 cm change from baseline | Standard Deviation 0.4 |
| Renuvion APR System | Change in Morphometric Breast Measurements at Day 180 | PROJ: maximum point of breast projection measured perpendicular to the chest wall | 0.3 cm change from baseline | Standard Deviation 1.2 |
| Renuvion APR System | Change in Morphometric Breast Measurements at Day 180 | N-N: measurements taken at the mid nipple diameter on both sides | 0 cm change from baseline | Standard Deviation 1.1 |
| Renuvion APR System | Change in Morphometric Breast Measurements at Day 180 | SSN-IMC: vertical distance from the suprasternal notch to the inframammary crease | -0.8 cm change from baseline | Standard Deviation 1 |
| Renuvion APR System | Change in Morphometric Breast Measurements at Day 180 | SSN-base: vertical distance from the suprasternal notch to the lowest point on the base | -1.5 cm change from baseline | Standard Deviation 1 |
Other Pre-specified
Change in Morphometric Breast Measurements at Day 30
Bilateral analysis of change to Morphometric breast measurements as per Brown, An Analysis of Ptosis at baseline and at D30.
Time frame: 30-Day
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Renuvion APR System | Change in Morphometric Breast Measurements at Day 30 | SNN-N: Suprasternal notch to nipple distance | -0.7 cm change from baseline | Standard Deviation 0.5 |
| Renuvion APR System | Change in Morphometric Breast Measurements at Day 30 | IMC-N: Inframammary crease to nipple distance | -0.3 cm change from baseline | Standard Deviation 0.5 |
| Renuvion APR System | Change in Morphometric Breast Measurements at Day 30 | MCL-N: Midclavicular line to nipple distance | -0.7 cm change from baseline | Standard Deviation 0.5 |
| Renuvion APR System | Change in Morphometric Breast Measurements at Day 30 | NAC: nipple-areola complex diameter | -0.1 cm change from baseline | Standard Deviation 0.4 |
| Renuvion APR System | Change in Morphometric Breast Measurements at Day 30 | PROJ: maximum point of breast projection measured perpendicular to the chest wall | -0.2 cm change from baseline | Standard Deviation 1.2 |
| Renuvion APR System | Change in Morphometric Breast Measurements at Day 30 | N-N: nipple to nipple distance | -0.3 cm change from baseline | Standard Deviation 1 |
| Renuvion APR System | Change in Morphometric Breast Measurements at Day 30 | SSN-IMC: vertical distance from the suprasternal notch to the inframammary crease | -0.5 cm change from baseline | Standard Deviation 0.6 |
| Renuvion APR System | Change in Morphometric Breast Measurements at Day 30 | SSN-base: vertical distance from the suprasternal notch to the lowest point on the base | -0.9 cm change from baseline | Standard Deviation 0.8 |
Other Pre-specified
Change in Morphometric Breast Measurements at Day 90
Bilateral analysis of change to Morphometric breast measurements as per Brown, An Analysis of Ptosis at baseline and at D90.
Time frame: 90-Day
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Renuvion APR System | Change in Morphometric Breast Measurements at Day 90 | SNN-N: measurements taken at the mid nipple diameter on both sides | -0.9 cm change from baseline | Standard Deviation 0.5 |
| Renuvion APR System | Change in Morphometric Breast Measurements at Day 90 | IMC-N: measurement taken from the base of the breast to the base of the nipple | -0.6 cm change from baseline | Standard Deviation 0.6 |
| Renuvion APR System | Change in Morphometric Breast Measurements at Day 90 | MCL-N: measurement taken from the mid clavicle to the mid nipple | -0.8 cm change from baseline | Standard Deviation 0.6 |
| Renuvion APR System | Change in Morphometric Breast Measurements at Day 90 | NAC: nipple-areola complex diameter | -01. cm change from baseline | Standard Deviation 0.5 |
| Renuvion APR System | Change in Morphometric Breast Measurements at Day 90 | PROJ: maximum point of breast projection measured perpendicular to the chest wall | 0 cm change from baseline | Standard Deviation 1.2 |
| Renuvion APR System | Change in Morphometric Breast Measurements at Day 90 | N-N: measurements taken at the mid nipple diameter on both sides | -0.3 cm change from baseline | Standard Deviation 1.1 |
| Renuvion APR System | Change in Morphometric Breast Measurements at Day 90 | SSN-IMC: vertical distance from the suprasternal notch to the inframammary crease | -0.7 cm change from baseline | Standard Deviation 0.8 |
| Renuvion APR System | Change in Morphometric Breast Measurements at Day 90 | SSN-base: vertical distance from the suprasternal notch to the lowest point on the base | -1.1 cm change from baseline | Standard Deviation 0.8 |
Other Pre-specified
Investigator Global Aesthetic Improvement Scale (GAIS) at Day 180
The investigator will grade the overall improvement of treatment area as very much improved, much improved, improved, no change, worse, much worse, or very much worse.
Time frame: 180-Day
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Renuvion APR System | Investigator Global Aesthetic Improvement Scale (GAIS) at Day 180 | Very Much Improved | 10 Participants |
| Renuvion APR System | Investigator Global Aesthetic Improvement Scale (GAIS) at Day 180 | Much Improved | 5 Participants |
| Renuvion APR System | Investigator Global Aesthetic Improvement Scale (GAIS) at Day 180 | Improved | 0 Participants |
| Renuvion APR System | Investigator Global Aesthetic Improvement Scale (GAIS) at Day 180 | No Change | 0 Participants |
| Renuvion APR System | Investigator Global Aesthetic Improvement Scale (GAIS) at Day 180 | Worse | 0 Participants |
| Renuvion APR System | Investigator Global Aesthetic Improvement Scale (GAIS) at Day 180 | Much Worse | 0 Participants |
| Renuvion APR System | Investigator Global Aesthetic Improvement Scale (GAIS) at Day 180 | Very Much Worse | 0 Participants |
Other Pre-specified
Investigator Global Aesthetic Improvement Scale (GAIS) at Day 30
The investigator will grade the overall improvement of treatment area as very much improved, much improved, improved, no change, worse, much worse, or very much worse.
Time frame: 30-Day
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Renuvion APR System | Investigator Global Aesthetic Improvement Scale (GAIS) at Day 30 | Improved | 4 Participants |
| Renuvion APR System | Investigator Global Aesthetic Improvement Scale (GAIS) at Day 30 | No Change | 0 Participants |
| Renuvion APR System | Investigator Global Aesthetic Improvement Scale (GAIS) at Day 30 | Very Much Improved | 1 Participants |
| Renuvion APR System | Investigator Global Aesthetic Improvement Scale (GAIS) at Day 30 | Much Improved | 10 Participants |
| Renuvion APR System | Investigator Global Aesthetic Improvement Scale (GAIS) at Day 30 | Worse | 0 Participants |
| Renuvion APR System | Investigator Global Aesthetic Improvement Scale (GAIS) at Day 30 | Much Worse | 0 Participants |
| Renuvion APR System | Investigator Global Aesthetic Improvement Scale (GAIS) at Day 30 | Very Much Worse | 0 Participants |
Other Pre-specified
Investigator Global Aesthetic Improvement Scale (GAIS) at Day 90
The investigator will grade the overall improvement of treatment area as very much improved, much improved, improved, no change, worse, much worse, or very much worse.
Time frame: 90-Day
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Renuvion APR System | Investigator Global Aesthetic Improvement Scale (GAIS) at Day 90 | Very Much Worse | 0 Participants |
| Renuvion APR System | Investigator Global Aesthetic Improvement Scale (GAIS) at Day 90 | Very Much Improved | 4 Participants |
| Renuvion APR System | Investigator Global Aesthetic Improvement Scale (GAIS) at Day 90 | Much Improved | 9 Participants |
| Renuvion APR System | Investigator Global Aesthetic Improvement Scale (GAIS) at Day 90 | Improved | 2 Participants |
| Renuvion APR System | Investigator Global Aesthetic Improvement Scale (GAIS) at Day 90 | No Change | 0 Participants |
| Renuvion APR System | Investigator Global Aesthetic Improvement Scale (GAIS) at Day 90 | Worse | 0 Participants |
| Renuvion APR System | Investigator Global Aesthetic Improvement Scale (GAIS) at Day 90 | Much Worse | 0 Participants |
Other Pre-specified
Patient Satisfaction Questionnaire (PSQ) at Day 180
Subjects will be asked to complete a satisfaction survey referring to the assessment of baseline photos, current photos, and a mirror. Yes/No - Did you notice any improvement in the laxity or sagginess of your breasts? If yes, checkbox - Less sagging, Breasts look higher on the chest, Nipple placement is improved, Breasts appear more youthful, and/or Other. How would you characterize your satisfaction with the treatment? - very satisfied, satisfied, slightly satisfied, neither satisfied or dissatisfied, slightly dissatisfied, dissatisfied, very dissatisfied. Yes/No - Would you recommend this treatment to your friends and family members?
Time frame: 180-Day
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Renuvion APR System | Patient Satisfaction Questionnaire (PSQ) at Day 180 | Yes, Improvement Noticed in Breast Area | 15 participants |
| Renuvion APR System | Patient Satisfaction Questionnaire (PSQ) at Day 180 | Yes, Less Sagging Breasts | 15 participants |
| Renuvion APR System | Patient Satisfaction Questionnaire (PSQ) at Day 180 | Yes, Breasts Look Higher on Chest | 15 participants |
| Renuvion APR System | Patient Satisfaction Questionnaire (PSQ) at Day 180 | Yes, Nipple Placement is Improved | 15 participants |
| Renuvion APR System | Patient Satisfaction Questionnaire (PSQ) at Day 180 | Yes, Breasts Appear More Youthful | 15 participants |
| Renuvion APR System | Patient Satisfaction Questionnaire (PSQ) at Day 180 | Yes, Would recommend to friends and family | 15 participants |
Other Pre-specified
Subject Global Aesthetic Improvement Scale (GAIS) at Day 180
The Subject will grade overall improvement of treatment area as very much improved, much improved, improved, no change, worse, much worse, or very much worse.
Time frame: 180-Day
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Renuvion APR System | Subject Global Aesthetic Improvement Scale (GAIS) at Day 180 | Very Much Improved | 10 Participants |
| Renuvion APR System | Subject Global Aesthetic Improvement Scale (GAIS) at Day 180 | Much Improved | 5 Participants |
| Renuvion APR System | Subject Global Aesthetic Improvement Scale (GAIS) at Day 180 | Improved | 0 Participants |
| Renuvion APR System | Subject Global Aesthetic Improvement Scale (GAIS) at Day 180 | No Change | 0 Participants |
| Renuvion APR System | Subject Global Aesthetic Improvement Scale (GAIS) at Day 180 | Worse | 0 Participants |
| Renuvion APR System | Subject Global Aesthetic Improvement Scale (GAIS) at Day 180 | Much Worse | 0 Participants |
| Renuvion APR System | Subject Global Aesthetic Improvement Scale (GAIS) at Day 180 | Very Much Worse | 0 Participants |
Other Pre-specified
Subject Global Aesthetic Improvement Scale (GAIS) at Day 30
The Subject will grade overall improvement of treatment area as very much improved, much improved, improved, no change, worse, much worse, or very much worse.
Time frame: 30-Day
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Renuvion APR System | Subject Global Aesthetic Improvement Scale (GAIS) at Day 30 | Very Much Improved | 1 Participants |
| Renuvion APR System | Subject Global Aesthetic Improvement Scale (GAIS) at Day 30 | Much Improved | 11 Participants |
| Renuvion APR System | Subject Global Aesthetic Improvement Scale (GAIS) at Day 30 | Improved | 3 Participants |
| Renuvion APR System | Subject Global Aesthetic Improvement Scale (GAIS) at Day 30 | No Change | 0 Participants |
| Renuvion APR System | Subject Global Aesthetic Improvement Scale (GAIS) at Day 30 | Worse | 0 Participants |
| Renuvion APR System | Subject Global Aesthetic Improvement Scale (GAIS) at Day 30 | Much Worse | 0 Participants |
| Renuvion APR System | Subject Global Aesthetic Improvement Scale (GAIS) at Day 30 | Very Much Worse | 0 Participants |
Other Pre-specified
Subject Global Aesthetic Improvement Scale (GAIS) at Day 90
The Subject will grade overall improvement of treatment area as very much improved, much improved, improved, no change, worse, much worse, or very much worse.
Time frame: 90-Day
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Renuvion APR System | Subject Global Aesthetic Improvement Scale (GAIS) at Day 90 | Very Much Improved | 4 Participants |
| Renuvion APR System | Subject Global Aesthetic Improvement Scale (GAIS) at Day 90 | Much Improved | 8 Participants |
| Renuvion APR System | Subject Global Aesthetic Improvement Scale (GAIS) at Day 90 | Improved | 3 Participants |
| Renuvion APR System | Subject Global Aesthetic Improvement Scale (GAIS) at Day 90 | No Change | 0 Participants |
| Renuvion APR System | Subject Global Aesthetic Improvement Scale (GAIS) at Day 90 | Worse | 0 Participants |
| Renuvion APR System | Subject Global Aesthetic Improvement Scale (GAIS) at Day 90 | Much Worse | 0 Participants |
| Renuvion APR System | Subject Global Aesthetic Improvement Scale (GAIS) at Day 90 | Very Much Worse | 0 Participants |