NCT04146467

Renuvion APR Device to Improve the Appearance of Lax Tissue in the Neck and Submental Region

A Prospective, Multi-Center, Evaluator-Blinded Study Evaluating the Safety and Effectiveness of the Renuvion APR Device to Improve the Appearance of Lax Tissue in the Neck and Submental Region

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Apyx Medical · Industry
• Sex: All
• Age: 35 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a prospective, multi-center, multi-phase, evaluator-blinded study of subjects undergoing a procedure with the Renuvion APR Device to improve the appearance of lax tissue in the neck and submental region.

Detailed description

This is a prospective, multi-center, multi-phase, evaluator-blinded study of subjects undergoing a procedure to improve the appearance of lax tissue in the neck and submental region. All study subjects will be treated with the Renuvion APR Device. Phase I (n=17) of this study will be conducted primarily to provide safety data, however, effectiveness data will also be collected at the above stated timepoints through 6 months post-procedure. Phase II (n=65) of this study is the expansion of the study to a pivotal study.

Conditions

• Lax Skin

Interventions

Type	Name	Description
DEVICE	Renuvion APR Device	The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.

Timeline

• Start date: 2019-11-26
• Primary completion: 2022-02-28
• Completion: 2022-02-28
• First posted: 2019-10-31
• Last updated: 2022-07-20
• Results posted: 2022-07-08

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study