This record was last updated February 18, 2025 (before its estimated March 1, 2025 completion). Its status may not reflect the trial's current state.
Summary
Objective:
The goal of this clinical trial is to evaluate the safety and efficacy of the VOLNEWMER monopolar radiofrequency device developed by CLASSYS Inc. This study is a prospective, single-center, single-arm, pilot clinical trial.
Research Questions:
1. Does the VOLNEWMER device improve skin elasticity?
2. Is the safety profile of the VOLNEWMER device acceptable?
Subject Procedures:
Subjects will:
* Receive a single treatment session using the VOLNEWMER device.
* Attend follow-up visits over a 12-week period to assess improvements in elasticity and safety.
The primary outcome is the improvement in skin elasticity of the face and cheeks, measured 12 weeks after treatment using the Cutometer R7. Secondary outcomes include the Global Aesthetic Improvement Scale (GAIS). Safety assessments involve monitoring treatment-emergent adverse events (TEAEs) associated with the application of the investigational medical device.
Protocol Amendment History
2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-02-04; most recent amendment 2025-02-16.
Status change: Recruiting → Active, Not Recruiting2025-02-12