CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 55 enrolled
Drug / intervention
Renuvion Dermal Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04185909
NCT04185909N/ACompleted
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A Prospective, Multicenter, Single Arm Clinical Study Evaluating the Use of the Renuvion Dermal System for Dermal Resurfacing

Apyx Medical·interventional·Posted Dec 4, 2019·Updated Jun 22, 2022

In Brief

A clinical study evaluating Renuvion Dermal System for Wrinkle and Rhytides. Completed, enrolled 55 participants across 4 sites.

Detailed Summary

This is a multi-center, single arm, evaluator-blind prospective study of up to 55 study subjects who are seeking a procedure to reduce the appearance of wrinkles and rhytides.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsWrinkle, Rhytides
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedDec 4, 2019
Enrollment StartDec 30, 2019
Primary CompletionMar 23, 2021
Study CompletionMay 13, 2021
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 6.6 years ago

Interventions

Renuvion Dermal Systemdevice

The Renuvion® Dermal System consists of an electrosurgical generator unit, a handpiece with detachable standoffs, and a supply of helium gas. Radio Frequency (RF) energy is delivered to the handpiece by the electrosurgical generator unit and used to energize an electrode. When helium gas is passed over the energized electrode, a helium plasma is generated which allows for conduction of the RF energy from the electrode to the subject in the form of a precise helium plasma beam.