CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 82 enrolled
Drug / intervention
Renuvion APR Devicedevice
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/NCT04146467
NCT04146467N/ACompleted
CompareCT.gov

A Prospective, Multi-Center, Evaluator-Blinded Study Evaluating the Safety and Effectiveness of the Renuvion APR Device to Improve the Appearance of Lax Tissue in the Neck and Submental Region

Apyx Medical·interventional·Posted Oct 31, 2019·Updated Jul 20, 2022

In Brief

A clinical study evaluating Renuvion APR Device for Lax Skin. Completed, enrolled 82 participants across 6 sites.

Detailed Summary

This is a prospective, multi-center, multi-phase, evaluator-blinded study of subjects undergoing a procedure with the Renuvion APR Device to improve the appearance of lax tissue in the neck and submental region.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLax Skin
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedOct 31, 2019
Enrollment StartNov 26, 2019
Primary CompletionFeb 28, 2022
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 6.7 years ago

Interventions

Renuvion APR Devicedevice

The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. 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 soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.