Clinical Evidence- Peer Reviewed Published Studies
Publication of clinical data in two premier peer-reviewed journals support the safety and efficacy of Ultrashape. These results are consistent with the clinical experience of hundreds of Physicians performing the Ultrashape procedure around the world.
The multi-center clinical trail results are published in the September 2007 issue of Plastic and Reconstructive Surgery, the Journal of the American Society of Plastic Surgeons. The article ‘Non-Invasive Body Contouring by Focused Ultrasound: Safety and Efficacy of the Ultrashape Contour I device in a multi-center Controlled Clinical Study’, Teitelbaum et al., is a report on 164 patients which shows durable and measureable circumference and fat thickness reduction of the abdomen, flanks and thighs after a single treatment without pain or downtime. No statistically significant weight loss was observed during the 84 day follow-up period. Therefore, the reduction in circumference was attributed to the treatment, not weight loss. Blood and urinalysis were performed at days 0, 1, 3, 7, 14, 21, 28, 56 and 84. No clinically significant elevation of serum lipid profiles and no clinically significant changes in blood and urine tests were seen. Liver ultrasound was performed before and after each treatment and there were no treatment induced changes to the liver. No serious adverse effects were observed, and great improvments in body shape
Clinical Evidence- Presented Abstracts
Dr. Hector Leal-Silva, dermatologic surgeon, Monterrey, Mexico presented results of his independent multi-treatment clinical study at the World Congress of Dermatology and American Society for Dermatologic Surgery annual meetings in 2007. The presentation entitled ‘Non-invasive Ultrasonic Selective Destruction of Adipocytes using Ultrashape’ reviewed a 36 patient clinical study using the Ultrashape system on localized fat deposits in the abdomen, flanks and thighs. The study showed definitive, measurable results in 100 percent of patients including an average of 5cm reduction in circumference in the abdomen after a series of three treatments, one month apart. CT scans taken in a subset of study subjects showed objectively quantifiable and incremental fat thickness reduction after each treatment. 94% of patients were satisfied with the procedure- no adverse events were reported.
Below are white papers, clinical studies and other published reports providing evidence of Ultrashape’s efficacy and safety…
PRS Ultrashape Published Study
Ultrashape Clinical Round Table- European Aesthetic Buyers Guide Spring 2007
Safety and Efficacy of the Contour I Device in a Multi-Center Controlled Clinical Study
Dr. Otto White Paper- Initial Experience
Ultrashape Article- Laser Surgery Medicine April 2007
For more white paper click here
