NCT03966924

The PREFORM Study: Rotational Fractional Resection for Submental Contouring

The PREFORM Study: An Exploratory, Single-Center Study to Evaluate the Safety and Efficacy of Rotational Fractional Resection on Submental Contouring and Optimal Peri-Procedure Regimen for Accelerated Recovery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (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. Rotational fractional resection is used to remove loose skin and fat.

Detailed description

This is a prospective, single-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 moderate to severe submental skin laxity. The total duration of study participation for each subject is approximately up to 4 months for each subject from the screening visit to the exit visit. The follow-up period will be approximately 3 months after the procedure. Eligible subjects will complete a total of 11 study visits: screening, procedure, and follow-up visits at 1, 4, 7, 14, 21, 30, 45, 60, and 90 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 with and without focal lipectomy (removal of loose skin and fat)

Timeline

• Start date: 2019-03-20
• Primary completion: 2019-10-16
• Completion: 2019-10-16
• First posted: 2019-05-29
• Last updated: 2021-05-11
• Results posted: 2021-02-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study