Measuring Renuvion Soft Tissue Contraction Using Ultrasound

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Skin Laxity
• Intervention / Treatment: Device: Renuvion APR Handpiece

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.

• Study Type: Interventional
• Enrollment (Estimated): 5
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kari Larson; Phone Number: 800-537-2790; Email: kari.larson@apyxmedical.com
• Study Contact Backup: Name: Emily Hughes; Phone Number: 800-537-2790; Email: emily.hughes@apyxmedical.com

Study Locations

• United States
  • Washington
    • Olympia, Washington, United States, 98501
      • Pearl Plastic Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Renuvion APR System Treatment; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analysis of contraction	Percentage of soft tissue contraction measured by an ultrasonographer on baseline ultrasound images compared to follow-up images.	Day 365

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IPR Review	Improvement in appearance of skin laxity in the treatment area assessed by selection of the correct post-treatment image as determined by a masked, qualitative assessment of photographs by blinded independent reviewers	Day 365
Physician Global Aesthetic Improvement	The Principal Investigator, sub-investigator or qualified clinician delegated by the principal investigator, will complete a PGAIS assessing overall aesthetic improvement in the treatment area	Day 365
Subject Global Aesthetic Improvement	The subject will complete a SGAIS assessing overall aesthetic improvement in the treatment area	Day 365
Patient Satisfaction	The subject will complete a Patient Satisfaction Questionnaire (PSQ)	Day 365
Energy Delivered	Analysis of energy delivered (J/cm2)	Day 0

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Analysis of adverse events	Day 365

Collaborators and Investigators

• Sponsor: Apyx Medical
• Investigators: Principal Investigator: Chris Nichols, Investigator; Principal Investigator: Dan Albershardt, Investigator

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: July 5, 2023
• First Submitted That Met QC Criteria: July 27, 2023
• First Posted (Actual): August 1, 2023

Study Record Updates

• Last Update Posted (Actual): September 18, 2023
• Last Update Submitted That Met QC Criteria: September 15, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Renuvion; Helium Plasma
• Additional Relevant MeSH Terms: Skin Diseases; Genetic Diseases, Inborn; Connective Tissue Diseases; Skin Diseases, Genetic; Cutis Laxa
• Other Study ID Numbers: APX-23-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No