Skin Laxity
Conditions
Keywords
Renuvion, Helium Plasma
Brief summary
This is a prospective, single-center, non-randomized study of up to 5 subjects who are receiving treatment with the Renuvion APR system following power-assisted liposuction in the abdomen per investigator standard of care. Ultrasound images of soft tissue contraction will be taken on abdomen prior to and during the procedure. Measurements of contraction will be calculated from the ultrasound images by an ultrasonographer. All adverse events and expected treatment effects will be documented. Follow-up photographs and ultrasound images will be captured at D30, D45, D60, D90, D180, D270, & D365.
Detailed description
This is a prospective, single-center, non-randomized study of up to 5 subjects who are receiving treatment with the Renuvion APR system following power-assisted liposuction in the abdomen per investigator standard of care. Subjects may also have other body areas treated at the same time. Demographic information, medical history, and procedure details will be documented. Pre- and post-procedure care are per investigator standard of care and documented. Video may be taken during the procedure. Ultrasound images of soft tissue contraction will be taken on abdomen prior to and during the procedure. Measurements of contraction will be calculated from the ultrasound images by an ultrasonographer. At baseline, photographs will be taken of the treatment areas. Surface area measurements will be taken of each treatment area prior to study treatment. Post-procedure care will be as per investigator standard of care and documented. All adverse events and expected treatment effects will be documented. Follow-up photographs and ultrasound images will be captured at D30, D45, D60, D90, D180, D270, & D365.
Interventions
DEVICERenuvion APR Handpiece
The Renuvion® APR (Apyx Plasma/RF) handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with a compatible generator for the delivery of radiofrequency energy and helium plasma for cutting, coagulation and ablation of soft tissue during open surgical procedures. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for cutting, coagulation or ablation of soft tissue during open surgical procedures. The compatible generators operate at an adjustable power of up to 40 W (expressed as 0 - 100% where 100% is 40 W) and provide an adjustable helium gas flow of 1 - 5 L/Min. APR Handpiece has a non-extendable electrode to generate helium plasma.
Sponsors
Apyx Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients who are scheduled for a procedure involving the use of Renuvion for the contraction of subcutaneous soft tissue. Patients undergoing procedures involving Renuvion alone and/or Renuvion following liposuction will be included. * Patients who have acceptable cardiopulmonary health for outpatient surgery. * Willing and able to comply with protocol requirements, including obtaining study-required images/photos and assessments, and returning for follow-up visits. * Willing to release rights for the use of study photos, including in potential publication. * Able to communicate with the site via video and/or photographs, in the event of a virtual follow-up visit. * Able to read, understand, sign and date the informed consent document (English only).
Exclusion criteria
* BMI of greater than 35. * Diabetes mellitus with A1C score \>7. * Active cigarette smokers or nicotine vape users. * History of connective tissue disease (Ehlers Danlos, Cutis Laxa, Pseudoxanthoma Elasticum, Marfan's, etc.) * Patients who, in the opinion of the investigator, is not an appropriate candidate for the study. * Patients requiring a concomitant procedure in the Renuvion treatment area that could impact the ultrasound measurements or the effectiveness results.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Analysis of Contraction From Baseline to Day 365 | Baseline, Day 365 | Percentage of soft tissue contraction measured by an ultrasonographer on baseline ultrasound images compared to follow-up images to quantify the total amount of connective tissue contraction produced by the Renuvion treatment between the skin and the Scarpa's fascia. A negative value indicates greater tissue contraction, while a positive value indicates less tissue contraction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IPR Review | Day 365 | Three experienced, blinded photographic reviewers performed a qualitative analysis/review of pre-treatment and post-treatment sets of images at 90-days, 180-days, 270-days, and 365-days post-treatment compared to baseline for each subject. Images were provided in a blinded and randomized order. Each blinded reviewer choose which set of images were the post-treated Renuvion images of the abdomen. Success was the correct identification of treated abdomen images by at least 2 of the 3 reviewers. |
| Physician Global Aesthetic Improvement | Day 60, Day 90, Day 180, Day 270, Day 365 | The Principal Investigator, sub-investigator or qualified clinician delegated by the principal investigator, will complete a PGAIS assessing overall aesthetic improvement in the treatment area. |
| Subject Global Aesthetic Improvement | Day 60, Day 90, Day 180, Day 270, Day 365 | The subject will complete a SGAIS assessing overall aesthetic improvement in the treatment area. |
| Patient Satisfaction | Day 180, Day 270, Day 365 | The subject will complete a Patient Satisfaction Questionnaire (PSQ) |
| Energy Delivered | Day 0 | Analysis of Energy per surface area was completed for all 5 subjects representing how much energy was delivered to each square centimeter of the abdomen's surface. The general pattern is that the energy per surface area decreases as the surface area of the abdomen increases. Analysis of energy delivered (kJ/cm2) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Renuvion APR System Treatment Subjects are receiving treatment with the Renuvion APR system following power-assisted liposuction in the abdomen per investigator standard of care. Subjects may also have other body areas treated at the same time.
Renuvion APR Handpiece: The Renuvion® APR (Apyx Plasma/RF) handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with a compatible generator for the delivery of radiofrequency energy and helium plasma for cutting, coagulation and ablation of soft tissue during open surgical procedures. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for cutting, coagulation or ablation of soft tissue during open surgical procedures. The compatible generators operate at an adjustable power of up to 40 W (expressed as 0 - 100% where 100% is 40 W) and provide an adjustable helium gas flow of 1 - 5 L/Min. APR Handpiece has a non-extendable electrode to generate helium plasma. | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | Renuvion APR System Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Age, Continuous | 48 Years STANDARD_DEVIATION 44 |
| BMI | 30.8 kg/m2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 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 | 5 Participants |
| Region of Enrollment United States | 5 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 5 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
Analysis of Contraction From Baseline to Day 365
Percentage of soft tissue contraction measured by an ultrasonographer on baseline ultrasound images compared to follow-up images to quantify the total amount of connective tissue contraction produced by the Renuvion treatment between the skin and the Scarpa's fascia. A negative value indicates greater tissue contraction, while a positive value indicates less tissue contraction.
Time frame: Baseline, Day 365
Population: During this initial study treatment, the investigators realized the importance of fully expressing the helium from the tissue prior to taking the intra-operative measurements as residual helium expands the subcutaneous tissue, resulting in inaccurate contraction measurements. Due to this discovery and the subsequent change in treatment technique for the remaining subjects, the data for subject 001-BBJ is excluded from the intra-operative data tables and analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renuvion APR System Treatment | Analysis of Contraction From Baseline to Day 365 | -44.0 percentage of contraction | Standard Deviation 17.2 |
Secondary
Energy Delivered
Analysis of Energy per surface area was completed for all 5 subjects representing how much energy was delivered to each square centimeter of the abdomen's surface. The general pattern is that the energy per surface area decreases as the surface area of the abdomen increases. Analysis of energy delivered (kJ/cm2)
Time frame: Day 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renuvion APR System Treatment | Energy Delivered | 0.037 kJ/cm2 | Standard Deviation 0.012 |
Secondary
IPR Review
Three experienced, blinded photographic reviewers performed a qualitative analysis/review of pre-treatment and post-treatment sets of images at 90-days, 180-days, 270-days, and 365-days post-treatment compared to baseline for each subject. Images were provided in a blinded and randomized order. Each blinded reviewer choose which set of images were the post-treated Renuvion images of the abdomen. Success was the correct identification of treated abdomen images by at least 2 of the 3 reviewers.
Time frame: Day 365
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Renuvion APR System Treatment | IPR Review | 18 Correctly identified sets of images |
Secondary
Patient Satisfaction
The subject will complete a Patient Satisfaction Questionnaire (PSQ)
Time frame: Day 180, Day 270, Day 365
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Renuvion APR System Treatment | Patient Satisfaction | Characterize Satisfaction with Procedure: Satisfied (Very, Satisfied, or Slightly) | 5 Participants |
| Renuvion APR System Treatment | Patient Satisfaction | Noticed improvement in how abdomen looks | 5 Participants |
| Renuvion APR System Treatment | Patient Satisfaction | Recommends Procedure to Friends and Family Members | 5 Participants |
| Renuvion APR System Treatment | Patient Satisfaction | Improvement Noticed: Improvement in wrinkles | 2 Participants |
| Renuvion APR System Treatment | Patient Satisfaction | Improvement Noticed: Less sagging skin | 5 Participants |
| Renuvion APR System Treatment | Patient Satisfaction | Improvement Noticed: Smoother skin texture | 3 Participants |
Secondary
Physician Global Aesthetic Improvement
The Principal Investigator, sub-investigator or qualified clinician delegated by the principal investigator, will complete a PGAIS assessing overall aesthetic improvement in the treatment area.
Time frame: Day 60, Day 90, Day 180, Day 270, Day 365
Population: One subject missed the D90 visit.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Renuvion APR System Treatment | Physician Global Aesthetic Improvement | Day 365 | Worse | 0 Participants |
| Renuvion APR System Treatment | Physician Global Aesthetic Improvement | Day 60 | Worse | 0 Participants |
| Renuvion APR System Treatment | Physician Global Aesthetic Improvement | Day 60 | No change | 0 Participants |
| Renuvion APR System Treatment | Physician Global Aesthetic Improvement | Day 60 | Improved, Much Improved, Very Much Improved | 5 Participants |
| Renuvion APR System Treatment | Physician Global Aesthetic Improvement | Day 90 | Worse | 0 Participants |
| Renuvion APR System Treatment | Physician Global Aesthetic Improvement | Day 90 | No change | 0 Participants |
| Renuvion APR System Treatment | Physician Global Aesthetic Improvement | Day 90 | Improved, Much Improved, Very Much Improved | 4 Participants |
| Renuvion APR System Treatment | Physician Global Aesthetic Improvement | Day 180 | Worse | 0 Participants |
| Renuvion APR System Treatment | Physician Global Aesthetic Improvement | Day 180 | No change | 0 Participants |
| Renuvion APR System Treatment | Physician Global Aesthetic Improvement | Day 180 | Improved, Much Improved, Very Much Improved | 5 Participants |
| Renuvion APR System Treatment | Physician Global Aesthetic Improvement | Day 270 | Worse | 0 Participants |
| Renuvion APR System Treatment | Physician Global Aesthetic Improvement | Day 270 | No change | 0 Participants |
| Renuvion APR System Treatment | Physician Global Aesthetic Improvement | Day 270 | Improved, Much Improved, Very Much Improved | 5 Participants |
| Renuvion APR System Treatment | Physician Global Aesthetic Improvement | Day 365 | No change | 0 Participants |
| Renuvion APR System Treatment | Physician Global Aesthetic Improvement | Day 365 | Improved, Much Improved, Very Much Improved | 5 Participants |
Secondary
Subject Global Aesthetic Improvement
The subject will complete a SGAIS assessing overall aesthetic improvement in the treatment area.
Time frame: Day 60, Day 90, Day 180, Day 270, Day 365
Population: One subject missed the D90 visit.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Renuvion APR System Treatment | Subject Global Aesthetic Improvement | Day 60 | Worse | 0 Participants |
| Renuvion APR System Treatment | Subject Global Aesthetic Improvement | Day 60 | No Change | 0 Participants |
| Renuvion APR System Treatment | Subject Global Aesthetic Improvement | Day 60 | Improved, Much Improved, Very Much Improved | 5 Participants |
| Renuvion APR System Treatment | Subject Global Aesthetic Improvement | Day 90 | Worse | 0 Participants |
| Renuvion APR System Treatment | Subject Global Aesthetic Improvement | Day 90 | No Change | 0 Participants |
| Renuvion APR System Treatment | Subject Global Aesthetic Improvement | Day 90 | Improved, Much Improved, Very Much Improved | 4 Participants |
| Renuvion APR System Treatment | Subject Global Aesthetic Improvement | Day 180 | Worse | 0 Participants |
| Renuvion APR System Treatment | Subject Global Aesthetic Improvement | Day 180 | No Change | 0 Participants |
| Renuvion APR System Treatment | Subject Global Aesthetic Improvement | Day 180 | Improved, Much Improved, Very Much Improved | 5 Participants |
| Renuvion APR System Treatment | Subject Global Aesthetic Improvement | Day 270 | Worse | 0 Participants |
| Renuvion APR System Treatment | Subject Global Aesthetic Improvement | Day 270 | No Change | 0 Participants |
| Renuvion APR System Treatment | Subject Global Aesthetic Improvement | Day 270 | Improved, Much Improved, Very Much Improved | 5 Participants |
| Renuvion APR System Treatment | Subject Global Aesthetic Improvement | Day 365 | Worse | 0 Participants |
| Renuvion APR System Treatment | Subject Global Aesthetic Improvement | Day 365 | No Change | 0 Participants |
| Renuvion APR System Treatment | Subject Global Aesthetic Improvement | Day 365 | Improved, Much Improved, Very Much Improved | 5 Participants |