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The CONFORM Study: A Multi-center Study to Evaluate the Safety and Efficacy of Rotational Fractional Resection on Submental Contouring
This study will evaluate the safety and efficacy of rotational fractional resection (RFR) to improve neck contouring. RFR is used to remove loose skin and fat.
This is a prospective, multi-center, single-arm (non-randomized), interventional cohort, non-significant risk (NSR) study designed to investigate the efficacy and safety of Rotational Fractional Resection (skin resection and focal lipectomy) in patients with mild to moderate submental fat and mild to moderate submental skin laxity. The total duration of study participation for each subject is approximately up to 7 months for each subject from the screening visit to the exit visit. The follow-up period will be approximately 6 months after the procedure. Eligible subjects will complete a total of 8 study visits: screening, procedure, and follow-up visits at 1, 7, 14, 30, 90 and 180 days post-procedure.
Age
30 - No limit years
Sex
ALL
Healthy Volunteers
Yes
Aesthetx
Campbell, California, United States
Steve Yoelin, MD Medical Associates, Inc.
Newport Beach, California, United States
Roseville Facial Plastic Surgery
Roseville, California, United States
Miami Dermatology & Laser Institute
Miami, Florida, United States
DeNova Research
Chicago, Illinois, United States
Sundaram Dermatology, Cosmetic & Laser Surgery Center
Fairfax, Virginia, United States
Start Date
January 8, 2018
Primary Completion Date
December 28, 2018
Completion Date
April 23, 2019
Last Updated
February 3, 2021
68
ACTUAL participants
Rotational fractional resection (1.5mm diameter device)
DEVICE
Lead Sponsor
Recros Medica, Inc.
NCT03087253
NCT06679270
NCT06941610
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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