NCT05665335

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Apyx Medical · Industry
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Detailed description

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. At baseline, the grade of breast ptosis, breast measurements and pre-surgery photographs will be taken using the site's camera system. Procedure data and adverse events will be captured. Follow-up visits will occur at 30, 90, and 180-days post-procedure. Subjects may also be seen back for follow-up at the investigator's discretion.

Conditions

• Breast Ptosis

Interventions

Type	Name	Description
DEVICE	Renuvion APR System	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.

Timeline

• Start date: 2022-11-28
• Primary completion: 2024-04-26
• Completion: 2024-04-26
• First posted: 2022-12-27
• Last updated: 2025-05-14
• Results posted: 2025-05-14

Locations

1 site across 1 country: Greece