At a glance
ClinicalIndex Comparison RecordN/ACompleted· 10 enrolled
Drug / intervention
Renuvion APR Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Evaluation of the Use of the Renuvion APR System in the Labia
In Brief
A clinical study evaluating Renuvion APR System for Labia Enlarged and Labium; Hypertrophy. Completed, enrolled 10 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLabia Enlarged, Labium; Hypertrophy
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
2023202420252026
First PostedApr 2022
Enrollment StartApr 2023
Primary CompletionApr 2024
TodayJul 2026
First PostedApr 12, 2022
Enrollment StartApr 19, 2023
Primary CompletionApr 23, 2024
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 4.2 years ago
Interventions
Renuvion APR Systemdevice
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.