NCT03853980

The INFORM Study: Rotational Fractional Resection for Submental Contouring

The INFORM Study: A Multi-Center Study to Evaluate the Safety and Efficacy of Rotational Fractional Resection on Submental Contouring With an Optimized Post-Procedure Treatment Plan

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Recros Medica, Inc. · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Accepted

Summary

Efficacy and safety of Rotational Fractional Resection (skin resection) in patients with moderate to severe submental skin laxity.

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) 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, 2-4, 7, 14, 21, 30, 45, 60, and 90 days post-procedure.

Conditions

• Skin Laxity

Interventions

Type	Name	Description
DEVICE	Focal Contouring System	Single treatment of skin resection (removal of loose skin)

Timeline

• Start date: 2019-03-18
• Primary completion: 2020-10-31
• Completion: 2020-10-31
• First posted: 2019-02-26
• Last updated: 2020-03-06

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated device study