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

NCT03756168 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-01-30

Study results available
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Summary

The objective of this clinical study is to assess the safety and efficacy of using a 1060 nm diode laser for non-invasive fat reduction of the flanks.

Conditions

  • Fat Atrophy

Interventions

DEVICE

1060nm Diode laser

All subjects received a single treatment with Venus Bliss' 1064 nm laser administered to the flanks Venus Bliss is a non-invasive medical aesthetic device designed for body contouring. The device contains four 1060 nm diode laser applicators which are 60x60 mm in size. It has a separate RF/PEMF applicator, but this was not used in this study. There is a belt included with the system to allow for the secure attachment of the applicators to the treatment area.

Sponsors & Collaborators

  • Venus Concept

    lead INDUSTRY

Principal Investigators

  • Suzanne Kilmer, MD · Skin and Laser Centre 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 NCT03756168 on ClinicalTrials.gov