Measuring Renuvion Soft Tissue Contraction Using Ultrasound

Skin Laxity Clinical Trial

Official title:

Measuring Renuvion Soft Tissue Contraction Using Ultrasound

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05968495
• Other study ID #: APX-23-02
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: September 2023
• Source: Apyx Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 5
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

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.

Related Conditions & MeSH terms

• Cutis Laxa
• Skin Laxity

Intervention

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.

Locations

Country	Name	City	State
United States	Pearl Plastic Surgery	Olympia	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Apyx Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse Events	Analysis of adverse events	Day 365
Primary	Analysis of contraction	Percentage of soft tissue contraction measured by an ultrasonographer on baseline ultrasound images compared to follow-up images.	Day 365
Secondary	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
Secondary	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
Secondary	Subject Global Aesthetic Improvement	The subject will complete a SGAIS assessing overall aesthetic improvement in the treatment area	Day 365
Secondary	Patient Satisfaction	The subject will complete a Patient Satisfaction Questionnaire (PSQ)	Day 365
Secondary	Energy Delivered	Analysis of energy delivered (J/cm2)	Day 0