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Post-Market Lower Eyelid Treatment With Renuvion in Greece

NCT05605691 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2025-03-26

Study results available
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Summary

This is a prospective, multi-center, non-randomized, single-arm study of up to 15 subjects treated with the Renuvion APR System. Subjects will receive treatment with the Renuvion APR System in the lower periorbital area on both sides of the face.

Conditions

  • Skin Laxity

Interventions

DEVICE

Renuvion APR System

The Renuvion Generator (K192867) is indicated for delivery of radiofrequency energy and/or helium plasma to cut, coagulate and ablate soft tissue during open and laparoscopic surgical procedures. The Renuvion APR Handpiece (K191542) is intended to be used with compatible electrosurgical generators for the delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue during open surgical procedures. Together, the Renuvion Generator and Handpiece are referred to as the Renuvion APR System.

Sponsors & Collaborators

  • Apyx Medical

    lead INDUSTRY

Principal Investigators

  • Aris Sterodimas, MD · Metropolitan General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-11
Primary Completion
2024-03-05
Completion
2024-03-05

Countries

  • Greece

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 NCT05605691 on ClinicalTrials.gov