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Renuvion/J-Plasma for Subdermal Skin Tightening and Contouring of the Upper Arms: Dissection Technique Comparison

NCT04902599 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2022-09-22

No results posted yet for this study

Summary

The Renuvion/J-plasma cold atmospheric plasma device has been in clinical use in aesthetics since its approval by the FDA in 2012, but no rigorous clinical trials have been published to quantify the effect of the skin tightening in any body area. In current clinical practice, the device is frequently used in conjunction with liposuction and both blunt and ultrasound assisted dissection cannulas are utilized. There is some thought that ultrasound assisted dissection may impart some tissue warming and skin tightening effects, but these effects are anecdotal at this time and not rigorously scientifically tested. Our study is designed to address these practice gaps by quantifying the improvement in skin laxity by objective measurements and comparing results obtained between blunt and ultrasound assisted dissection techniques without concurrent liposuction.

This study will use a single-blind, prospective, right-left sided comparator design to assess the effect of the Renuvion/J-Plasma CAP device on skin tightening of upper extremity skin laxity and compare the effect of blunt dissection versus ultrasound assisted site preparation on the procedure results in a non-inferiority design. This study will be a prospective, single-blind (assessor), randomized right-left sided, non-inferiority clinical trial.

Procedures:

This is a randomized, right-left arm, single blinded, prospective noninferiority clinical trial comparing ultrasound assisted to traditional blunt dissection in site preparation prior to subdermal application of the Renuvion/J-plasma cold atmospheric plasma (CAP) device while quantitatively evaluating the efficacy of the Renuvion device.

A total of 15 patients will be enrolled. Dropout is anticipated to be low as the study visits will concur with routine clinical follow up appointments. The number needed to treat to show noninferiority between blunt dissection and ultrasound assisted dissection is 13 and the number needed to treat to show statistically significant difference between baseline and follow up is 3 for the Renuvion/J-Plasma procedure.

Conditions

  • Subdermal Skin Tightening

Interventions

PROCEDURE

Renuvion/j-Plasma procedure using blunt dissection technique

Renuvion/j-Plasma procedure using blunt dissection technique

PROCEDURE

Renuvion/j-Plasma procedure using ultrasound-guided dissection technique

Renuvion/j-Plasma procedure using ultrasound-guided dissection technique.

Sponsors & Collaborators

Principal Investigators

  • David Smart, M.D. · University of Utah MidValley Dermatology

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-17
Primary Completion
2022-08-30
Completion
2022-08-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04902599 on ClinicalTrials.gov