Clinical Evaluation of a 1060 nm Diode Laser, PEMF and Vacuum Assisted MP RF for Non-invasive Fat… (NCT04012814) | Clinical Trial Compass
CompletedNot Applicable
Clinical Evaluation of a 1060 nm Diode Laser, PEMF and Vacuum Assisted MP RF for Non-invasive Fat Reduction
United States39 participantsStarted 2019-09-19
Plain-language summary
Open-label, baseline-controlled, multi-center study evaluating a 1060 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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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.
3\. BMI score is less than 35. 4. Agree to not making any major changes in their diet or lifestyle during the course of the study.
5\. Able and willing to comply with the treatment/follow-up schedule and requirements.
6\. 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 in the last 3 months, 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 maligna…