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Clinical Evaluation of the Safety and Efficacy of a 1060nm Diode Laser (Abdomen)

NCT03756350 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-07-03

Study results available
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Summary

This study is evaluating a 1060nm diode laser for non-invasive fat reduction of the abdomen. The study will enrolled up to 50 subjects requesting non-invasive lipolysis of the abdomen. Each subject will receive a single study treatment. Subjects will be followed at six and twelve weeks post treatment. Twelve week outcomes will be compared to baseline.

Conditions

  • Fat Atrophy

Interventions

DEVICE

1060nm diode laser

Non-invasive medical aesthetic device designed for body contouring. The device is comprised of a console, four 1060nm diode laser applicators which are 60x60 mm in size. There is a belt included with the system to allow for the secure application of the applicators to the treatment area.

Sponsors & Collaborators

  • Venus Concept

    lead INDUSTRY

Principal Investigators

  • Suzanne Kilmer, MD · Skin and Laser Surgery Center of Northern California

  • Jeffery Kenkel, MD · UT Southwestern

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-14
Primary Completion
2019-07-02
Completion
2019-07-02
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 NCT03756350 on ClinicalTrials.gov