Measuring Renuvion Soft Tissue Contraction Using Ultrasound

NCT ID: NCT05968495

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2024-09-30

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Renuvion APR Handpiece

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Apyx Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chris Nichols

Role: PRINCIPAL_INVESTIGATOR

Investigator

Dan Albershardt

Role: PRINCIPAL_INVESTIGATOR

Investigator

Locations

Pearl Plastic Surgery

Olympia, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

APX-23-02

Identifier Type: -

Identifier Source: org_study_id