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Renuvion Dermal System for Dermal Resurfacing

NCT04185909 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2022-06-22

Study results available
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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.

Conditions

  • Wrinkle
  • Rhytides

Interventions

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.

Sponsors & Collaborators

  • Apyx Medical

    lead INDUSTRY

Principal Investigators

  • Edward Zimmerman, MD · Aesthetic Revolution Las Vegas

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-12-30
Primary Completion
2021-03-23
Completion
2021-05-13
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT04185909 on ClinicalTrials.gov