A Prospective, Multi-Center, Evaluator-Blinded Study Evaluating the Safety and Effectiveness of the Renuvion APR Device to Improve the Appearance of Lax Tissue in the Neck and Submental Region
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Lax Skin
- Sponsor
- Apyx Medical
- Enrollment
- 82
- Locations
- 6
- Primary Endpoint
- Day 180 Number of Participants With Improvement Measured By Independent Photographic Review
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
This is a prospective, multi-center, multi-phase, evaluator-blinded study of subjects undergoing a procedure with the Renuvion APR Device to improve the appearance of lax tissue in the neck and submental region.
Detailed Description
This is a prospective, multi-center, multi-phase, evaluator-blinded study of subjects undergoing a procedure to improve the appearance of lax tissue in the neck and submental region. All study subjects will be treated with the Renuvion APR Device. Phase I (n=17) of this study will be conducted primarily to provide safety data, however, effectiveness data will also be collected at the above stated timepoints through 6 months post-procedure. Phase II (n=65) of this study is the expansion of the study to a pivotal study.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female subjects 35-65 years of age (inclusive).
- •Healthy as determined by the investigator examining the subject.
- •Seeking improvement of the appearance of lax tissue in the neck and submental region.
- •Females of childbearing potential who are sexually active must be willing to use an approved method of birth control during study participation.
- •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.
- •Understands and accepts the obligation not to have significant weight loss or weight gain (≥8 pounds) post the treatment, and for the duration of participation in the study.
- •Willing to abstain from the use of blood thinners (including, but not limited to, Coumadin, NSAIDS, Ibuprofen, vitamin K, other) for 2 weeks (14 days) prior to the procedure.
- •Willing to abstain from smoking, vaping, or the use of e-cigarettes for 1 year prior to and for the entire duration of participation in the study.
- •Willing to abstain from the use of marijuana for 2 weeks prior to and for the duration of participation in the study.
Exclusion Criteria
- •Pregnant or lactating.
- •Pregnancy within 12 months prior to screening.
- •Use within 24 hours preceding surgery of ibuprofen, acetaminophen, any other analgesics, anti-inflammatory products, or any products including herbals and supplements that could interfere with the clinical assessments of this study (other than drugs used for anesthesia).
- •Allergy to tumescent anesthetic (lidocaine/epinephrine).
- •Excessive subcutaneous fat in the treatment area (as determined by the treating investigator).
- •Active systemic or local skin disease that may alter wound healing.
- •Significant or uncontrolled medical condition that, in the opinion of the investigator, participation in the study may compromise the patient's health.
- •Severe solar elastosis.
- •History of autoimmune disease (excluding Hashimoto's thyroiditis).
- •Known hypersensitivity or adverse reaction to anesthetics.
Outcomes
Primary Outcomes
Day 180 Number of Participants With Improvement Measured By Independent Photographic Review
Time Frame: 180-Day
Improvement in the appearance of lax tissue in the neck and submental region at 6 months as determined by qualitative 2D photography assessment by blinded Independent Photographic Reviewers. Three experienced, blinded photographic reviewers performed a qualitative analysis/review of the pre-treatment and post-treatment sets of images of each subject in a blinded and randomized order. Each blinded reviewer chose which image was the post-treatment image. Success was correct post-treatment image selection by at least 2 of the 3 reviewers. The percentage of subjects with a correct post-treatment image selection was calculated.
Subject Reported Pain - None to Moderate
Time Frame: Day 7
The primary safety endpoint is the level of pain and discomfort after treatment as reported by the subject on an 11-point Numeric Rating Scale (NRS) through the 7-day follow-up visit where 0 is no pain and 10 is the most pain. Pain scores are classified as scores of 0 being no pain, 1 - 5 is minor pain, 6 - 7 is moderate pain, and 8 - 10 is severe pain. The primary safety objective is to demonstrate that the proportion of subjects with none-to- moderate pain exceeds the performance goal (PG). The performance goal is 55%.