An interventional study of Renuvion APR Handpiece in Skin Laxity, sponsored by Apyx Medical. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-03.
Sponsored by Apyx Medical · Not applicable, Interventional, and Treatment
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.
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.
Apyx Medical is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 8 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: 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.
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
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
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
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
Patient Satisfaction
The subject will complete a Patient Satisfaction Questionnaire (PSQ)
Time frame: Day 180, Day 270, Day 365
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
| Milestone | Renuvion APR System Treatment |
|---|---|
| Started | 5 |
| Completed | 5 |
| Not completed | 0 |
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.
| percentage of contraction | Renuvion APR System Treatment |
|---|---|
| Analysis of Contraction From Baseline to Day 365 | -44.0 ± 17.2 |
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.
| Correctly identified sets of images | Renuvion APR System Treatment |
|---|---|
| IPR Review | 18 |
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.
| Participants | Renuvion APR System Treatment |
|---|---|
| Day 60 — Worse | 0 |
| Day 60 — No change | 0 |
| Day 60 — Improved, Much Improved, Very Much Improved | 5 |
| Day 90 — Worse | 0 |
| Day 90 — No change | 0 |
| Day 90 — Improved, Much Improved, Very Much Improved | 4 |
| Day 180 — Worse | 0 |
| Day 180 — No change | 0 |
| Day 180 — Improved, Much Improved, Very Much Improved | 5 |
| Day 270 — Worse | 0 |
| Day 270 — No change | 0 |
| Day 270 — Improved, Much Improved, Very Much Improved | 5 |
| Day 365 — Worse | 0 |
| Day 365 — No change | 0 |
| Day 365 — Improved, Much Improved, Very Much Improved | 5 |
The subject will complete a SGAIS assessing overall aesthetic improvement in the treatment area.
| Participants | Renuvion APR System Treatment |
|---|---|
| Day 60 — Worse | 0 |
| Day 60 — No Change | 0 |
| Day 60 — Improved, Much Improved, Very Much Improved | 5 |
| Day 90 — Worse | 0 |
| Day 90 — No Change | 0 |
| Day 90 — Improved, Much Improved, Very Much Improved | 4 |
| Day 180 — Worse | 0 |
| Day 180 — No Change | 0 |
| Day 180 — Improved, Much Improved, Very Much Improved | 5 |
| Day 270 — Worse | 0 |
| Day 270 — No Change | 0 |
| Day 270 — Improved, Much Improved, Very Much Improved | 5 |
| Day 365 — Worse | 0 |
| Day 365 — No Change | 0 |
| Day 365 — Improved, Much Improved, Very Much Improved | 5 |
The subject will complete a Patient Satisfaction Questionnaire (PSQ)
| Participants | Renuvion APR System Treatment |
|---|---|
| Characterize Satisfaction with Procedure: Satisfied (Very, Satisfied, or Slightly) | 5 |
| Noticed improvement in how abdomen looks | 5 |
| Recommends Procedure to Friends and Family Members | 5 |
| Improvement Noticed: Improvement in wrinkles | 2 |
| Improvement Noticed: Less sagging skin | 5 |
| Improvement Noticed: Smoother skin texture | 3 |
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)
| kJ/cm2 | Renuvion APR System Treatment |
|---|---|
| Energy Delivered | 0.037 ± 0.012 |
Collected over 365 Days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Renuvion APR System Treatment | 0/5 (0%) | 0/5 (0%) | 5/5 (100%) |
| Event | Renuvion APR System Treatment |
|---|---|
| SeromaSurgical and medical procedures | 3/5 |
| Subcutaneous NoduleSkin and subcutaneous tissue disorders | 3/5 |
| Hypoesthesia/numbness (ETE)Skin and subcutaneous tissue disorders | 1/5 |
| Age, Categorical(Participants) | Renuvion APR System Treatment |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 5 |
| >=65 years | 0 |
| Age, Continuous(Years) | Renuvion APR System Treatment |
|---|---|
| Median | 48 ± 44 |
| Sex: Female, Male(Participants) | Renuvion APR System Treatment |
|---|---|
| Female | 4 |
| Male | 1 |
| Ethnicity (NIH/OMB)(Participants) | Renuvion APR System Treatment |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 5 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Renuvion APR System Treatment |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 5 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Renuvion APR System Treatment |
|---|---|
| United States | 5 |
| BMI(kg/m2) | Renuvion APR System Treatment |
|---|---|
| Mean | 30.8 (24.55 to 36.61) |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jun 2023 to primary completion in Sep 2024, 15 months.
Results were first posted in Feb 2025, 4 months after primary completion.
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Cutis Laxa
Apyx Medical