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FDA approved device for fat tissue reduction in abdomen

Trial ID:
IRB-22-7972
E. Victor Ross, M.D.
This study will evaluate the safety and effectiveness of a FDA approved device for the reduction of fat tissue and/or improvement of muscle tone in the abdomen. The cosmetic device uses a laser and an applicator that combines radio frequency (RF) and pulsed electromagnetic fields (PEMF) including vacuum suction, and an electrical muscle stimulation (EMS) mode. Participation in this study requires attending 7-8 study visits over a 5-6 month period. Study visits will take place at the Scripps Clinic Carmel Valley.

Inclusion Criteria

Patients must:
  • - Be 18-65 years of age
  • - Agree to refrain from any new abdominal training exercises during the course of the study
  • - Have BMI of 30 or above
  • - Meet all other eligibility criteria

Exclusion Criteria

Patients must not:
  • - Be pregnant, intending to become pregnant, or nursing
  • - Have any previous liposuction/lipo-sculpture or any type of surgical procedure in the treatment area in the past 12 months
  • - Have a history of immunosuppression/immune deficiency disorders (including AIDS and HIV infection) or use of immunosuppressive medications in the last 6 months prior to and during the course of the study
  • - Have a history of hyperlipidemia, diabetes mellitus, hepatitis, blood coagulopathy or excessive bleeding, or cancer
  • - Have a permanent implant in the treatment area
  • - Use medications, herbs, food supplements, and vitamins known to induce photosensitivity to light exposure at the wavelength used or have a history of photosensitivity disorder
  • - Have tattoos in the treatment area

Additional Info

  • The purpose of this study is to determine whether the laser and RF study treatment combined with EMS together will reduce fat tissue and also tone muscle in the abdomen area. Also, the study will investigate whether the effects of the study treatments are maintained at 4 weeks and at 12 weeks.

Contact Info:

  • Clinical Research Services
  • CRSLeadership@scrippshealth.org