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NCT04902599 · ClinicalTrials.gov registry record · NA
Renuvion/J-Plasma for Subdermal Skin Tightening and Contouring of the Upper Arms: Dissection Technique Comparison
A NA study, sponsored by University of Utah.
- Terminated
- Registry status
- NA
- Development phase
- 3
- Enrollment target
NCT04902599 is a NA study that was terminated before completion, run by University of Utah. The registered enrollment target is 3 participants.
The verdict
NCT04902599, a NA study, was terminated before completion, sponsored by University of Utah.
- TERMINATED
- Registry status
- NA
- Development phase
- 3 participants
- Enrollment target
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 signif
Interventions
- PROCEDURE Renuvion/j-Plasma procedure using blunt dissection technique
- PROCEDURE Renuvion/j-Plasma procedure using ultrasound-guided dissection technique
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2020-09-17 |
| Est. Completion | 2022-08-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04902599
The ClinicalTrials.gov registry entry for NCT04902599 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Utah, which has 818 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Renuvion/j-Plasma procedure using blunt dissection technique is the first listed.
NCT04902599 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04902599 about?
NCT04902599 is a clinical study titled "Renuvion/J-Plasma for Subdermal Skin Tightening and Contouring of the Upper Arms: Dissection Technique Comparison". 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 frequentl...
What is the current status of trial NCT04902599?
This trial is currently terminated. It is a NA study. The enrollment target is 3 participants. The study started on 2020-09-17. Estimated completion is 2022-08-30.
What interventions are being tested in trial NCT04902599?
The interventions under investigation include: Renuvion/j-Plasma procedure using blunt dissection technique (PROCEDURE), Renuvion/j-Plasma procedure using ultrasound-guided dissection technique (PROCEDURE).
Who is sponsoring clinical trial NCT04902599?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
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