Measuring Renuvion Soft Tissue Contraction Using Ultrasound

Apyx Medical

Status: Completed

Conditions: Skin Laxity

Treatments: Device: Renuvion APR Handpiece

Study type: Interventional

Funder types: Industry

Identifiers

NCT05968495

APX-23-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

5 participants in 1 patient group

Renuvion APR System Treatment

Experimental group

Description:

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.

Treatment:

Device: Renuvion APR Handpiece