Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:04 PM
Ignite Modification Date:
2025-12-24 @ 2:04 PM
NCT ID:
NCT05968495
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05968495
Study Brief:
Protocol Section:
NCT05968495