Subject Evaluation of a 1064nm Diode Laser/RF

Withdrawn before enrolling · Not applicable

Conditions studied: Subcutaneous Fat Disorder

In brief

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.

Key facts

Study ID

NCT04090853

Run by

Venus Concept

People needed

0

Starts

2019-10-01

Expected to finish

2020-07-08

Last updated by the study team

2023-05-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• 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.
• Tattoos in the treatment area.
• Poor skin quality (severe laxity).
• Abdominal wall, muscular abnormality or hernia on physical examination.
• Use of retinoids such as oral isotretinoin (Accutane™) within the past six months or during course of the study.
• History of keloid or hypertrophic scar formation or poor wound healing in the treatment area.
• As per the investigator's discretion, any physical or mental condition which may make it unsafe for the subject to participate.
• Unable or unlikely to refrain from sun exposure, artificial tanning, including the use of tanning booths, prior to (six weeks) and during the course of the evaluation.

Where it is running

• Shah Aesthetic Surgery — Denver, Colorado, United States
• Medical Management Solutions INC — Foxborough, Massachusetts, United States
• SRS Dermatology — Woodmere, New York, United States

Full record on ClinicalTrials.gov

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