A Post-Market Study in Greece of a Minimally Invasive Breast Lift Procedure Utilizing the Renuvion APR System

NCT05665335 | Completed Results

• 1 other identifier: APX-22-03-GR
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, non-randomized, single-center, evaluator blinded study of up to 15 subjects undergoing a minimally invasive breast lift procedure utilizing the Renuvion APR System. Subjects will receive treatment with the Renuvion APR System to both breasts.

Conditions

Breast Ptosis

Outcome Measures

Primary Outcomes (1)

• Independent Photographic Review of Before and After Images Compared to Baseline Compared to D180.

  Improvement in breast ptosis as determined by a masked, qualitative assessment of photographs at 180-days post-treatment compared to baseline by blinded independent reviewers.

  180-Day

Secondary Outcomes (1)

• Independent Photographic Review of Before and After Images Compared to Baseline at D90.

  90-Day

Other Outcomes (16)

• Change in Morphometric Breast Measurements at Day 30

  30-Day

• Change in Morphometric Breast Measurements at Day 90

  90-Day

• Change in Morphometric Breast Measurements at Day 180

  180-Day

Study Arms (1)

Renuvion APR System

EXPERIMENTAL

Subjects treated with the Renuvion APR system in both breasts.

Device: Renuvion APR System

Interventions

Renuvion APR System DEVICE

The treatment area is defined as superior most not to exceed a horizontal line from the superior aspect of the axilla to the midline; inferior most not to cross the junction of the breast with the abdomen (inframammary fold). Lateral border to the outermost curvature of the breast or a vertical line drawn from the preaxillary line to the IMF; medial most to the innermost curvature of the breast up to 1 cm lateral to the sternal midline. The procedure will be in the intradermal and subdermal planes in the full breast area, without penetrating the breast gland. Renuvion APR System settings will be 60-70% Power, 1.5 LPM, and up to 6 retrograde or 3 antegrade/retrograde passes, with a minimum of 2 incision sites.

Renuvion APR System

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: Female subjects
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female subjects, ages 18 - 75 years old.
• ASA Physical Status Classification System Class I and Class II subjects.
• Breast Ptosis Class II and Class III as per the Eyck et al, Rainbow Scale for Assessing Breast Ptosis.
• Breast Cup Size A and Size B.
• 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.

You may not qualify if:

• Subjects presenting with ASA Physical Status Classification System Classes III or higher.
• Breast ptosis Class IV or more as per the Eyck et al, Rainbow Scale for Assessing Breast Ptosis.
• Breast Cup Size C, Size D or larger.
• Prior surgery or procedure in the breast area (i.e., implants, skin tightening procedures, breast reduction, etc.).
• 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 treatment 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.

Sponsors & Collaborators

• Apyx Medical: lead

Study Sites (1)

Metropolitan General Hospital

Athens, 15562, Greece

Location

Related Publications (1)

• Sterodimas A, Moutafis A, Nicaretta B, Champsas G. A Prospective Study on Helium-Based Plasma Radiofrequency for Minimally Invasive Breast Lift Scarless Mastopexy. Aesthet Surg J Open Forum. 2025 Mar 5;7:ojaf004. doi: 10.1093/asjof/ojaf004. eCollection 2025.

  PMID: 40236884 RESULT

Results Point of Contact

• Title: Kari Larson, Sr. Director of Clinical Affairs
• Organization: Apyx Medical

kari.larson@apyxmedical.com

8012440058

Study Officials

• Aris Sterodimas, MD, MSc, PhD

  Metropolitan General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2022
• First Posted: December 27, 2022
• Study Start: November 28, 2022
• Primary Completion: April 26, 2024
• Study Completion: April 26, 2024
• Last Updated: May 14, 2025
• Results First Posted: May 14, 2025

Record last verified: 2025-04

Locations

GR (1)