Measuring Renuvion Soft Tissue Contraction Using Ultrasound

NCT05968495 | Completed Results FDA Device

• 1 other identifier: APX-23-02
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Skin Laxity

Keywords

Renuvion; Helium Plasma

Outcome Measures

Primary Outcomes (1)

• Analysis of Contraction From Baseline to Day 365

  Percentage of soft tissue contraction measured by an ultrasonographer on baseline ultrasound images compared to follow-up images to quantify the total amount of connective tissue contraction produced by the Renuvion treatment between the skin and the Scarpa's fascia. A negative value indicates greater tissue contraction, while a positive value indicates less tissue contraction.

  Baseline, Day 365

Secondary Outcomes (5)

• IPR Review

  Day 365

• Physician Global Aesthetic Improvement

  Day 60, Day 90, Day 180, Day 270, Day 365

• Subject Global Aesthetic Improvement

  Day 60, Day 90, Day 180, Day 270, Day 365

• Patient Satisfaction

  Day 180, Day 270, Day 365

• Energy Delivered

  Day 0

Study Arms (1)

Renuvion APR System Treatment

EXPERIMENTAL

Subjects 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.

Device: Renuvion APR Handpiece

Interventions

Renuvion APR Handpiece DEVICE

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.

Renuvion APR System Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are scheduled for a procedure involving the use of Renuvion for the contraction of subcutaneous soft tissue. Patients undergoing procedures involving Renuvion alone and/or Renuvion following liposuction will be included.
• Patients who have acceptable cardiopulmonary health for outpatient surgery.
• Willing and able to comply with protocol requirements, including obtaining study-required images/photos and assessments, and returning for follow-up visits.
• Willing to release rights for the use of study photos, including in potential publication.
• Able to communicate with the site via video and/or photographs, in the event of a virtual follow-up visit.
• Able to read, understand, sign and date the informed consent document (English only).

You may not qualify if:

• BMI of greater than 35.
• Diabetes mellitus with A1C score \>7.
• Active cigarette smokers or nicotine vape users.
• History of connective tissue disease (Ehlers Danlos, Cutis Laxa, Pseudoxanthoma Elasticum, Marfan's, etc.)
• Patients who, in the opinion of the investigator, is not an appropriate candidate for the study.
• Patients requiring a concomitant procedure in the Renuvion treatment area that could impact the ultrasound measurements or the effectiveness results.

Sponsors & Collaborators

• Apyx Medical: lead

Study Sites (1)

Pearl Plastic Surgery

Olympia, Washington, 98501, United States

Location

MeSH Terms

Conditions

Cutis Laxa

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Results Point of Contact

• Title: Christopher Nichols, MD
• Organization: Pearl Plastic Surgery

cnichols@pearlplasticsurgery.com

360-878-9300

Study Officials

• Chris Nichols

  Investigator

  PRINCIPAL INVESTIGATOR

• Dan Albershardt

  Investigator

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2023
• First Posted: August 1, 2023
• Study Start: June 1, 2023
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: February 3, 2025
• Results First Posted: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)