NCT05605691

Post-Market Lower Eyelid Treatment With Renuvion in Greece

A Post-Market Study In Greece Of A Minimally Invasive Lower Eyelid Treatment Utilizing The Renuvion System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Apyx Medical · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Detailed description

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. At baseline, images will be taken utilizing the site's camera system. Baseline images will be used as comparator images for follow-up images for Independent Photographic Reviewer evaluation and subject/investigator assessments. The treatment area will be tumesced with 20 - 25ml of fluid on each side of the periorbital area. The treatment of the periorbital area will be accessed from an incision placed in the crease of the lower lid. Two incisions will be placed in both the medial and lateral crease of the lower lid. Treatment will be performed through one incision and the second incision will be used to allow for adequate venting of helium gas. Care will be taken to undermine the tissue and to ensure the incisions communicate with each other to allow adequate venting. An optional third lower lid incision may be made as needed. The treatment plane will be above the orbicularis muscle. The treatment settings will be 20% Power, 1 LPM, and 3 Passes. Procedure data and adverse events will be captured. Follow-up will occur 1 day, 3 days, 7 days, 30 days, 90 days, and 180 days post-procedure; images will be taken at all visits. Investigator/subjects assessments will be completed at D30, D90, and D180 visits. Subjects may also be seen back for follow-up at the investigator's discretion.

Conditions

• Skin Laxity

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-10-11
• Primary completion: 2024-03-05
• Completion: 2024-03-05
• First posted: 2022-11-04
• Last updated: 2025-03-26
• Results posted: 2025-03-26

Locations

1 site across 1 country: Greece