Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

Measuring Renuvion Soft Tissue Contraction Using Ultrasound

Lead Sponsor:

Apyx Medical

Conditions:

Skin Laxity

Eligibility:

All Genders

18-65 years

Phase:

NA

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 investig...

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 investig...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

June 1 2023

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 30 2024

Estimated Enrollment :

5 Patients enrolled

Trial Details

Trial ID

NCT05968495

Start Date

June 1 2023

End Date

September 30 2024

Last Update

February 3 2025

Active Locations (1)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (1 locations)

1

Pearl Plastic Surgery

Olympia, Washington, United States, 98501