N/A
Completed N=5
Measuring Renuvion Soft Tissue Contraction Using Ultrasound
Skin Laxity
Source: ClinicalTrials.gov NCT05968495 ↗
Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcomePrimary: Analysis of Contraction From Baseline to Day 365 — -44.0 percentage of contraction
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Analysis of Contraction From Baseline to Day 365 |
-44.0 | — |
| SECONDARY IPR Review |
18 | — |
| SECONDARY Physician Global Aesthetic Improvement |
0; 0; 5; 0; 0; 4 | — |
| SECONDARY Subject Global Aesthetic Improvement |
0; 0; 5; 0; 0; 4 | — |
| SECONDARY Patient Satisfaction |
5; 5; 5; 2; 5; 3 | — |
| SECONDARY Energy Delivered |
0.037 | — |
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.
Data sourced from ClinicalTrials.gov (NCT05968495). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.