WithdrawnNot Applicable

Subject Evaluation of a 1064nm Diode Laser/RF

Stopped: Slow enrolment and Covid19

United States0Started 2019-10-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Able to read, understand and voluntarily provide written informed consent.
✓. Healthy male or female, ≥ 18 years of age seeking treatment for unwanted fat in the flanks and or abdomen
✓. BMI score is less than 35.
✓. Able and willing to comply with the treatment/follow-up schedule and requirements.
✓. 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

✕. Pregnant, intending to become pregnant, postpartum or nursing in the last 6 months.
✕. Any previous liposuction/lipo-sculpture or any type of surgical procedure in the treatment area in the past 12 months.
✕. 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.
✕. History of hyperlipidemia, diabetes mellitus, hepatitis, blood coagulopathy or excessive bleeding.
✕. Use of antiplatelet medications (81 mg acetylsalicylic acid daily permitted), anticoagulants, thrombolytics or anti-inflammatory medications within 2 weeks of treatment.
✕. 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.
✕. 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).
✕. Use of medications, herbs, food supplements, and vitamins known to induce photosensitivity to light exposure at the wavelength used or history of photosensitivity disorder.

What they're measuring

Patient Overall Satisfaction

Timeframe: Week 26

Patient Treatment Satisfaction

Timeframe: Week 26

Trial details

NCT IDNCT04090853

SponsorVenus Concept

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-07-08

View on ClinicalTrials.gov More Subcutaneous Fat Disorder trials