NCT05323630

Evaluation of the Use of the Renuvion APR System in the Labia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Apyx Medical · Industry
• Sex: Female
• Age: 35 Years – 70 Years
• Healthy volunteers: Accepted

Summary

Labiaplasty is a procedure aimed at reducing lax or loose skin in the labia majora and/or minora due to childbirth, trauma, aging, genetics, or congenital disease.

Detailed description

While traditional surgical procedures have been associated with complications such as dehiscence, hematoma, flap necrosis, narrowed introitus, and pain and asymmetry, correction with RF energy has shown minimal complication rates with high patient satisfaction. This study aims to evaluate the use of the Renuvion APR System for use as a minimally invasive alternative to surgical labiaplasty.

Conditions

• Labia Enlarged
• Labium; Hypertrophy

Interventions

Type	Name	Description
DEVICE	Renuvion APR System	The Apyx Medical Corporation Renuvion/J-Plasma helium plasma family of products has received FDA clearance under 510(k) numbers K191542, K192867 for the cutting, coagulation, and ablation of soft tissue.

Timeline

• Start date: 2023-04-19
• Primary completion: 2024-04-23
• Completion: 2024-04-23
• First posted: 2022-04-12
• Last updated: 2025-12-23
• Results posted: 2025-12-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study