Measuring Renuvion Soft Tissue Contraction Using Ultrasound

Not Applicable

Completed

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Renuvion APR System Treatment	Renuvion APR Handpiece	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.

Primary Outcome Measures

Name	Time	Method
Analysis of Contraction From Baseline to Day 365	Baseline, 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.

Secondary Outcome Measures

Name	Time	Method
IPR Review	Day 365	Three experienced, blinded photographic reviewers performed a qualitative analysis/review of pre-treatment and post-treatment sets of images at 90-days, 180-days, 270-days, and 365-days post-treatment compared to baseline for each subject. Images were provided in a blinded and randomized order. Each blinded reviewer choose which set of images were the post-treated Renuvion images of the abdomen. Success was the correct identification of treated abdomen images by at least 2 of the 3 reviewers.
Physician Global Aesthetic Improvement	Day 60, Day 90, Day 180, Day 270, Day 365	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.
Subject Global Aesthetic Improvement	Day 60, Day 90, Day 180, Day 270, Day 365	The subject will complete a SGAIS assessing overall aesthetic improvement in the treatment area.
Patient Satisfaction	Day 180, Day 270, Day 365	The subject will complete a Patient Satisfaction Questionnaire (PSQ)
Energy Delivered	Day 0	Analysis of Energy per surface area was completed for all 5 subjects representing how much energy was delivered to each square centimeter of the abdomen's surface. The general pattern is that the energy per surface area decreases as the surface area of the abdomen increases. Analysis of energy delivered (kJ/cm2)