Brief Title
CONFORM: Rotational Fractional Resection for Submental Contouring
Official Title
The CONFORM Study: A Multi-center Study to Evaluate the Safety and Efficacy of Rotational Fractional Resection on Submental Contouring
Brief Summary
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.
Detailed Description
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.
Study Type
Interventional
Primary Outcome
Number of Participants With a Reduction of Submental Skin Area ≥ 20 mm^2
Secondary Outcome
Number of Participants Who Were Satisfied With the Appearance of Their Neck and Jawline
Condition
Skin Laxity
Intervention
Rotational fractional resection (1.5mm diameter device)
Study Arms / Comparison Groups
Rotational fractional resection (1.5mm diameter device)
Description: Single treatment of skin resection and focal lipectomy (removal of loose skin and fat)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
68
Start Date
January 8, 2018
Completion Date
April 23, 2019
Primary Completion Date
December 28, 2018
Eligibility Criteria
Inclusion Criteria: - Healthy male or female, at least 30 years old - Moderate submental (neck) fat - Mild to moderate submental (neck) skin laxity (loose skin) - Willing and able to provide informed consent - Willing and able to comply with all protocol requirements - Willing to limit direct sun exposure and use sunscreen for duration of the study - Agree to maintain weight for duration of the study - Willing to have photographs taken that could identify the participant Exclusion Criteria: - Previous intervention to treat submental fat or skin laxity - Use of aspirin, ibuprofen, naproxen, or Vitamin E within 14 days of the procedure - Sensitivity to local anesthesia - Severe acne, cystic acne or acne scars on neck - Trauma of chin or neck area - Skin infection or rash on neck - Psoriasis, eczema, rosacea, or vitiligo - History of scarring - History or current symptoms of dysphagia - Chronic or persistent coughing - Body mass index (BMI) > 30 - Clinically significant bleeding disorder - Anemia, kidney disease, or liver disease
Gender
All
Ages
30 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Edward W Knowlton, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03407313
Organization ID
CLP-0002
Responsible Party
Sponsor
Study Sponsor
Recros Medica, Inc.
Study Sponsor
Edward W Knowlton, MD, Study Director, Recros Medica, Inc.
Verification Date
January 2021