The objectives of this study are to evaluate the safety and effectiveness of procedural analgesia for improvements in tolerability of treatment with the Liposonix System.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Treatment of subcutaneous adipose tissue of the abdomen using high intensity focused ultrasound (Liposonix System Model 2).
Pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)
Solta Medical Aesthetic Center
Hayward, California, United States
Pain Score for Overall Treatment
Following treatment, the subject was asked to evaluate the pain level for the overall treatment using the 0-10 Visual Analog Scale (0 represents no pain and 10 represents worst imaginable pain)
Time frame: Baseline
Safety Assessment
Adverse events will be assessed and documented throughout the study
Time frame: Baseline, 1 day, 1 week
Pain Scores Reported at 1-day Post-Treatment
During the 1-day follow-up phone call, subjects were asked to rate the pain they were currently experiencing from the Liposonix treatment using a 0-10 pain scale (0 represents no pain and 10 represents worst pain imaginable).
Time frame: 1 day
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