NCT04185909

Renuvion Dermal System for Dermal Resurfacing

A Prospective, Multicenter, Single Arm Clinical Study Evaluating the Use of the Renuvion Dermal System for Dermal Resurfacing

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Apyx Medical · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Accepted

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.

Detailed description

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. All study subjects will be treated with the Renuvion Dermal System. The study population will consist of males and females, 30 years of age or older, requesting a procedure for the purpose of improving facial appearance by reducing facial wrinkles and rhytides. Those subjects who meet eligibility criteria and agree to provide written informed consent will be invited to participate.

Conditions

• Wrinkle
• Rhytides

Interventions

Type	Name	Description
DEVICE	Renuvion Dermal System	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.

Timeline

• Start date: 2019-12-30
• Primary completion: 2021-03-23
• Completion: 2021-05-13
• First posted: 2019-12-04
• Last updated: 2022-06-22
• Results posted: 2022-06-03

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study