NCT05968495

Measuring Renuvion Soft Tissue Contraction Using Ultrasound

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Apyx Medical · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a prospective, single-center, non-randomized study of up to 5 subjects who are receiving treatment with the Renuvion APR system following power-assisted liposuction in the abdomen per investigator standard of care. Ultrasound images of soft tissue contraction will be taken on abdomen prior to and during the procedure. Measurements of contraction will be calculated from the ultrasound images by an ultrasonographer. All adverse events and expected treatment effects will be documented. Follow-up photographs and ultrasound images will be captured at D30, D45, D60, D90, D180, D270, \& D365.

Detailed description

This is a prospective, single-center, non-randomized study of up to 5 subjects who are receiving treatment with the Renuvion APR system following power-assisted liposuction in the abdomen per investigator standard of care. Subjects may also have other body areas treated at the same time. Demographic information, medical history, and procedure details will be documented. Pre- and post-procedure care are per investigator standard of care and documented. Video may be taken during the procedure. Ultrasound images of soft tissue contraction will be taken on abdomen prior to and during the procedure. Measurements of contraction will be calculated from the ultrasound images by an ultrasonographer. At baseline, photographs will be taken of the treatment areas. Surface area measurements will be taken of each treatment area prior to study treatment. Post-procedure care will be as per investigator standard of care and documented. All adverse events and expected treatment effects will be documented. Follow-up photographs and ultrasound images will be captured at D30, D45, D60, D90, D180, D270, \& D365.

Conditions

• Skin Laxity

Interventions

Type	Name	Description
DEVICE	Renuvion APR Handpiece	The Renuvion® APR (Apyx Plasma/RF) handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with a compatible generator for the delivery of radiofrequency energy and helium plasma for cutting, coagulation and ablation of soft tissue during open surgical procedures. 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 cutting, coagulation or ablation of soft tissue during open surgical procedures. The compatible generators operate at an adjustable power of up to 40 W (expressed as 0 - 100% where 100% is 40 W) and provide an adjustable helium gas flow of 1 - 5 L/Min. APR Handpiece has a non-extendable electrode to generate helium plasma.

Timeline

• Start date: 2023-06-01
• Primary completion: 2024-09-30
• Completion: 2024-09-30
• First posted: 2023-08-01
• Last updated: 2025-02-03
• Results posted: 2025-02-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study