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Subject Evaluation of a 1064nm Diode Laser/RF | Clinical Trials | Clareo Health

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Subject Evaluation of a 1064nm Diode Laser/RF

Subject Evaluation of the Efficacy of a 1064 nm Diode Laser, Pulsed Electro-Magnetic Fields and Vacuum Assisted Multipolar Radio Frequency for Non-invasive Contouring of the Abdomen and Flanks

NCT04090853•Venus Concept

View on ClinicalTrials.gov

Summary

Open-label, baseline-controlled, multi-center study evaluating a 1064 nm diode laser, pulsed electromagnetic fields and vacuum assisted radio frequency for non-invasive fat reduction of the abdomen and flanks.

Detailed Description

The study will enroll up to 200 subjects requesting non-invasive lipolysis of the abdomen and flanks. Each subject will receive up to 3 study treatments of the diode laser and up to 3 treatments of the pulsed electromagnetic fields and vacuum assisted radio frequency study treatments. Subjects will be followed at 24 weeks post diode treatments to observe their satisfaction with treatment outcomes.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Able to read, understand and voluntarily provide written informed consent.
•2. Healthy male or female, ≥ 18 years of age seeking treatment for unwanted fat in the flanks and or abdomen
•3. BMI score is less than 35.
•4. Able and willing to comply with the treatment/follow-up schedule and requirements.
•5. Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment and for the duration of the study, and have a negative Urine Pregnancy test at baseline.

Exclusion Criteria

•1. Pregnant, intending to become pregnant, postpartum or nursing in the last 6 months.
•2. Any previous liposuction/lipo-sculpture or any type of surgical procedure in the treatment area in the past 12 months.
•3. History of immunosuppression/immune deficiency disorders (including AIDS and HIV infection) or use of immunosuppressive medications, 6 months prior to and during the course of the study.
•4. History of hyperlipidemia, diabetes mellitus, hepatitis, blood coagulopathy or excessive bleeding.
•5. Use of antiplatelet medications (81 mg acetylsalicylic acid daily permitted), anticoagulants, thrombolytics or anti-inflammatory medications within 2 weeks of treatment.
•6. Having a history of skin cancer or any other cancer in the areas to be treated, including presence of malignant or pre-malignant pigmented lesions.
•7. Having a permanent implant in the treatment area such as metal plates or an injected chemical substance such as silicone or parenteral gold therapy (gold sodium thiomalate).
•8. Use of medications, herbs, food supplements, and vitamins known to induce photosensitivity to light exposure at the wavelength used or history of photosensitivity disorder.
•9. Suffering from significant skin conditions in the treatment area or inflammatory skin conditions including but not limited to open lacerations, abrasions, herpes sores, cold sores, active infections.
•10. Tattoos in the treatment area.
+6 more criteria

Locations (3)

Shah Aesthetic Surgery

Denver, Colorado, United States

Medical Management Solutions INC

Foxborough, Massachusetts, United States

SRS Dermatology

Woodmere, New York, United States

Key Dates

Start Date

October 1, 2019

Primary Completion Date

July 8, 2020

Completion Date

July 8, 2020

Last Updated

May 8, 2023

Conditions

Subcutaneous Fat Disorder

Interventions

Venus Bliss

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 8, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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