Adults 18 to 65, any sex, with Skin Laxity. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Analysis of Contraction From Baseline to Day 365Primary· 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.
Group
Value
95% CI
Renuvion APR System Treatment
-44.0
± 17.2
IPR ReviewSecondary· 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.
Group
Value
95% CI
Renuvion APR System Treatment
18
Physician Global Aesthetic ImprovementSecondary· 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.
Day 60
Group
Value
95% CI
Renuvion APR System Treatment
0
Renuvion APR System Treatment
0
Renuvion APR System Treatment
5
Day 90
Group
Value
95% CI
Renuvion APR System Treatment
0
Renuvion APR System Treatment
0
Renuvion APR System Treatment
4
Day 180
Group
Value
95% CI
Renuvion APR System Treatment
0
Renuvion APR System Treatment
0
Renuvion APR System Treatment
5
Day 270
Group
Value
95% CI
Renuvion APR System Treatment
0
Renuvion APR System Treatment
0
Renuvion APR System Treatment
5
Day 365
Group
Value
95% CI
Renuvion APR System Treatment
0
Renuvion APR System Treatment
0
Renuvion APR System Treatment
5
Subject Global Aesthetic ImprovementSecondary· Day 60, Day 90, Day 180, Day 270, Day 365
The subject will complete a SGAIS assessing overall aesthetic improvement in the treatment area.
Day 60
Group
Value
95% CI
Renuvion APR System Treatment
0
Renuvion APR System Treatment
0
Renuvion APR System Treatment
5
Day 90
Group
Value
95% CI
Renuvion APR System Treatment
0
Renuvion APR System Treatment
0
Renuvion APR System Treatment
4
Day 180
Group
Value
95% CI
Renuvion APR System Treatment
0
Renuvion APR System Treatment
0
Renuvion APR System Treatment
5
Day 270
Group
Value
95% CI
Renuvion APR System Treatment
0
Renuvion APR System Treatment
0
Renuvion APR System Treatment
5
Day 365
Group
Value
95% CI
Renuvion APR System Treatment
0
Renuvion APR System Treatment
0
Renuvion APR System Treatment
5
Patient SatisfactionSecondary· Day 180, Day 270, Day 365
The subject will complete a Patient Satisfaction Questionnaire (PSQ)
Characterize Satisfaction with Procedure: Satisfied (Very, Satisfied, or Slightly)
Group
Value
95% CI
Renuvion APR System Treatment
5
Noticed improvement in how abdomen looks
Group
Value
95% CI
Renuvion APR System Treatment
5
Recommends Procedure to Friends and Family Members
Group
Value
95% CI
Renuvion APR System Treatment
5
Improvement Noticed: Improvement in wrinkles
Group
Value
95% CI
Renuvion APR System Treatment
2
Improvement Noticed: Less sagging skin
Group
Value
95% CI
Renuvion APR System Treatment
5
Improvement Noticed: Smoother skin texture
Group
Value
95% CI
Renuvion APR System Treatment
3
Energy DeliveredSecondary· 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)
Group
Value
95% CI
Renuvion APR System Treatment
0.037
± 0.012
Adverse events — posted to ClinicalTrials.gov
Time frame: 365 Days.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Apyx Medical
Last refreshed: 3 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05968495.