A Multi‐Site, Single‐Blinded, Prospective Pilot Clinical Trial for Non‐Invasive Fat Reduction of the Abdomen and Flanks Using a Monopolar 2 MHz Radiofrequency Device

A Multi‐Site, Single‐Blinded, Prospective Pilot Clinical Trial for Non‐Invasive Fat Reduction of the Abdomen and Flanks Using a Monopolar 2 MHz Radiofrequency Device

Background and Objectives Demand for non‐invasive body sculpting procedures has been steadily increasing, spurring the development of new energy‐based technologies. This study assessed the safety and efficacy of a new monopolar 2 MHz radiofrequency (RF) device for fat reduction of the flanks and abd...

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Bibliographic Details
Published in:Lasers in surgery and medicine Vol. 53; no. 3; pp. 337 - 343
Main Authors: Somenek, Michael T., Ronan, Stephen J., Pittman, Troy A.
Format: Journal Article
Language:English
Published: United States 01-03-2021
Subjects:
Abdomen - diagnostic imaging
Abdomen - surgery
adipocytes
Adiposity
body contouring
Cosmetic Techniques
fat reduction
Humans
monopolar
Prospective Studies
Radio Waves
radiofrequency
Treatment Outcome
Ultrasonography
monopolar
body contouring
adipocytes
radiofrequency
fat reduction
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Summary:Background and Objectives Demand for non‐invasive body sculpting procedures has been steadily increasing, spurring the development of new energy‐based technologies. This study assessed the safety and efficacy of a new monopolar 2 MHz radiofrequency (RF) device for fat reduction of the flanks and abdomen. Study Design/Materials and Methods Nineteen subjects from two clinical sites were enrolled in this study and received a single 15‐minute treatment with the 2 MHz RF device. Up to six applicators were placed on the abdomen and/or flanks during the treatment. Follow‐up assessments were scheduled 12 weeks after treatment. Efficacy evaluations included live ratings and Global Aesthetic Improvement Scale (GAIS) ratings by blinded investigators, ultrasound measurements of fat thickness, and patient‐reported outcomes before and after treatment. Results Investigator assessments showed more than one‐point change in the GAIS scale at the 12‐week follow‐up visit. Ultrasound measurements revealed a significant reduction in fat thickness in both the abdomen (average 24%) and the flanks (22%). The majority of the patients were satisfied with the treatment and mild self‐resolving side effects were observed. No serious adverse events were reported. Conclusions Treatment of local adiposities with a new monopolar 2 MHz radiofrequency device leads to improvement of body contour with no downtime or side effects. Lasers Surg. Med. © 2020 Wiley Periodicals LLC
Bibliography:Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported.
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ISSN:0196-8092
1096-9101
DOI:10.1002/lsm.23295