Post-Market Lower Eyelid Treatment With Renuvion in Greece

Status Completed

Clinical Trial Summary

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05605691
Study type	Interventional
Source	Apyx Medical
Contact
Status	Completed
Phase	N/A
Start date	October 11, 2022
Completion date	March 5, 2024

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT06140628` - A 28-day Clinical Study on Facial Skin Rejuvenation	N/A
Completed	`NCT01713985` - Feasibility Study: Evaluation of Ulthera Versus Thermage for Treating the Face and Neck	N/A
Completed	`NCT01971736` - Efficacy of Long Pulsed 1064nm Laser for Facial Skin Tightening	N/A
Completed	`NCT01713998` - Treatment of the Face and Neck With Lower Ulthera System Energy Settings	N/A
Completed	`NCT01708252` - Feasibility Study: Treatment of Post-surgery and Surgery Naive Patients Who Failed to Respond to a Previous Ulthera Treatment	N/A
Completed	`NCT01708382` - Feasibility Study: Lifting and Tightening of the Elbows	N/A
Completed	`NCT04296201` - Evaluation of the Immediate Effect and Safety of DMA™ Novel Muscle Stimulation Technology	N/A
Completed	`NCT06000839` - A Safety and Effectiveness Study of CELLBOOSTER® Lift (Stabilized Booster Complex Using CHAC Technology)	N/A
Completed	`NCT06366503` - Evaluating Procedure Pairing of a Post-Procedure Cream Versus a Comparator in Patients Treated With Fractional Ablative CO2 Laser for Facial Rejuvenation	N/A
Completed	`NCT05929625` - Radiofrequency and Ultrasound for Improvement of Skin Laxity and Wrinkles: Efficacy and Safety Evaluation	N/A
Terminated	`NCT01713569` - Feasibility Study: Histological Characterization After Treatment With the Ulthera® System	N/A
Completed	`NCT01519934` - A Retrospective Study to Evaluate the Effectiveness of the Ulthera System	N/A
Completed	`NCT04477187` - Clinical Assessment of Skin Tightening and Contour Change of Submental Tissue Using Bipolar Radiofrequency Microneedling	N/A
Completed	`NCT05590364` - Aesthetic Performance and Tolerance of an Injective Intradermal Treatment for the Skin Roughness and Laxity of Back of the Hands	N/A
Active, not recruiting	`NCT06243744` - Histological Evaluation of Human Skin Bx to Assess the Effects of APR Tx as an Adjunct Procedure in Facelift Surgery	N/A
Completed	`NCT04146584` - Safety and Efficacy of SofWave Treatment to Lift Lax Tissue in the Submental and Neck Zones and to Lift the Eyebrow	Phase 2
Recruiting	`NCT05750901` - Evaluation of Fractional Ablative Laser Treatment for Skin Conditions	N/A
Completed	`NCT04721600` - Evaluation of the Evoke Radiofrequency Device for Improvement of Skin Appearance	N/A
Recruiting	`NCT06157567` - Clinical Feasibility Study to Evaluate the Safety and Performance of the Profound Matrix System	N/A
Recruiting	`NCT05847530` - Pilot Evaluation of the Cynosure Potenza™ System for Treatment of Cosmetic Dermatologic Skin Conditions	N/A