Post-Market Lower Eyelid Treatment With Renuvion in Greece

NCT ID: NCT05605691

Last Updated: 2025-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-11
• Study Completion Date: 2024-03-05

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Renuvion APR System Treatment

Subject will be treated with the Renuvion APR system in the lower eyelid (periorbital) area.

Group Type: EXPERIMENTAL

Renuvion APR System

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Male or female subjects, ages 18 - 75 years old.
• ASA Physical Status Classification System Class I and Class II subjects.
• Complaint of skin laxity or lines in the lower eyelid area.
• Understands and accepts the obligation not to undergo any other procedures or treatments in the areas to be treated during study participation.
• Absence of physical conditions unacceptable to the investigator.
• Females of childbearing potential who are sexually active must be willing to use an approved method of birth control during study participation.
• Willing and able to comply with protocol requirements, including study-required images/photos, assessments/measurements, and returning for follow-up visits.
• Willing to release rights for the use of study photos, including in publication.
• Able to read, understand, sign, and date the informed consent.
• Able to communicate with the site via video and/or photographs, in the event of a virtual follow-up visit.

Exclusion Criteria

• Subjects presenting with ASA Physical Status Classification System Classes III or higher.
• Festoons in the periorbital area.
• Prior cosmetic/aesthetic fillers (hyaluronic acid, poly-l-lactic acid, calcium hydroxylapatite, et.) in the study treatment area within the past 12 months.
• Pregnant, lactating, or plans to become pregnant during study participation.
• Known hypersensitivity or allergy to tumescent anesthetic (lidocaine/ epinephrine).
• Known hypersensitivity or allergy to ibuprofen or other NSAIDS.
• Previous surgery in the study treatment area.
• Active systemic or local skin disease that may alter wound healing.
• Significant or uncontrolled medical condition that in the opinion of the investigator participation in the study may compromise the patient's health.
• History of autoimmune disease (excluding Hashimoto's thyroiditis).
• Known susceptibility to keloid formation or hypertrophic scarring.
• Cancerous or pre-cancerous lesions in the area to be treated.
• Possesses a surgically implanted electronic device (i.e., pacemaker).
• Serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in the past two years.
• Participation in any other investigational study within 30 days prior to consent and throughout study participation.
• Subject who, in the opinion of the investigator, is not an appropriate candidate for the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Apyx Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aris Sterodimas, MD

Role: PRINCIPAL_INVESTIGATOR

Metropolitan General Hospital

Locations

Metropolitan General Hospital

Athens, , Greece

Countries

Greece

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

APX-22-04

Identifier Type: -

Identifier Source: org_study_id