NCT03407313

CONFORM: Rotational Fractional Resection for Submental Contouring

The CONFORM Study: A Multi-center Study to Evaluate the Safety and Efficacy of Rotational Fractional Resection on Submental Contouring

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Recros Medica, Inc. · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Accepted

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.

Conditions

• Skin Laxity
• Lipodystrophy

Interventions

Type	Name	Description
DEVICE	Rotational fractional resection (1.5mm diameter device)	Single treatment of skin resection and focal lipectomy (removal of loose skin and fat)

Timeline

• Start date: 2018-01-08
• Primary completion: 2018-12-28
• Completion: 2019-04-23
• First posted: 2018-01-23
• Last updated: 2021-02-03
• Results posted: 2021-02-03

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study