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The PREFORM Study: Rotational Fractional Resection for Submental Contouring

NCT03966924 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2021-05-11

Study results available
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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.

Conditions

  • Skin Laxity
  • Lipodystrophy

Interventions

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)

Sponsors & Collaborators

  • Recros Medica, Inc.

    lead INDUSTRY

Principal Investigators

  • Robin McIntosh · Recros Medica

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-20
Primary Completion
2019-10-16
Completion
2019-10-16
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03966924 on ClinicalTrials.gov