Multiple CoolSculpting Treatment Study
- Conditions
- Body Fat Disorder
- Interventions
- Device: The Zeltiq CoolSculpting System
- Registration Number
- NCT01814007
- Lead Sponsor
- Zeltiq Aesthetics
- Brief Summary
To evaluate the safety of same-day CoolSculpting treatments and to assess the impact on serum lipids and liver-related tests.
- Detailed Description
The study will evaluate the safety of multiple same-day CoolSculpting treatments and will assess any impact on serum lips or liver-related analytes,
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CoolSculpting Treatment Group The Zeltiq CoolSculpting System CoolSculpting treatments will be performed on all subjects with 1 cooling cycle on the lower abdomen, plus simultaneous treatment of both flanks, one cooling cycle each. Two control units will be utilized at protocol-defined temperatures and durations.
- Primary Outcome Measures
Name Time Method Evaluation of Liver- Related Tests Over Time Pre-treatment; 1 week, 4 weeks, and 12 weeks post-treatment Blood draws will be collected pre-treatment, 1-week, 4-weeks, 12-weeks post treatment. Changes in each analyte was evaluated for consistency with normal variation and for change relative to the reference range of the component (high/low), pre-treatment versus post-treatment by an independent physician. The independent physician reviewer was provided with laboratory results and other pertinent information for each subject, including demographic, medical history, and concomitant medications. For every change in laboratory value over time, the reviewer was required to make a determination of whether the change in value represented a clinically meaningful change. In addition, for any change in a laboratory value that exceeded 25% change, or any value outside of normal range, the reviewer was required to provide a written rationale for the determination of clinical meaningfulness.
Safety of the Device and/or Procedure as Assessed by the Incidence of SAE and UADE 12 weeks post treatment The primary safety end point is the incidence of Serious Adverse Events (SAE) and Unanticipated Adverse Device Effects (UADE).
Evaluation of Liver-Related Tests Over Time Pretreatment, 1 week, 4 weeks 12 weeks post-treatment Blood draws will be collected pre-treatment, 1-week, 4-weeks, 12-weeks post treatment. Changes in each analyte was evaluated for consistency with normal variation and for change relative to the reference range of the component (high/low), pre-treatment versus post-treatment by an independent physician. The independent physician reviewer was provided with laboratory results and other pertinent information for each subject, including demographic, medical history, and concomitant medications. For every change in laboratory values over time, the reviewer was required to make a determination of whether the change in value represented a clinically meaningful change. In addition, for any change in a laboratory value that exceeded 25% change, or any value outside of normal range, the reviewer was required to provide a written rationale for the determination of clinical meaningfulness.
Evaluation of Serum Lipid Values Over Time Pre-treatment, 1 week, 4 weeks, 12 weeks post-treatment Blood draws will be collected pre-treatment, 1-week, 4-weeks, 12-weeks post treatment. Changes in each analyte was evaluated for consistency with normal variation and for change relative to the reference range of the component (high/low), pre-treatment versus post-treatment by an independent physician. The independent physician reviewer was provided with laboratory results and other pertinent information for each subject, including demographic, medical history, and concomitant medications. For every change in laboratory values over time, the reviewer was required to make a determination of whether the change in value represented a clinically meaningful change. In addition, for any change in a laboratory value that exceeded 25% change, or any value outside of normal range, the reviewer was required to provide a written rationale for the determination of clinical meaningfulness.
- Secondary Outcome Measures
Name Time Method Side Effects in Treatment Area Treatment day and 12 week post-treatment follow-up Clinical assessments of the skin at the treatment sites to be performed immediately post-treatment, and at the 12 week follow-up visit. Subjects will be evaluated for skin changes at the treatment sites. The scale used by clinicians for the assessments is 0 = absent, 1= minor, 2= moderate, 3= severe.
Pain: Assessment of Pain Scores Reported on the Day of Treatment and at 12 Weeks Post-treatment. Treatment day and 12 week post-treatment follow-up Pain scores are collected using a 0 (no pain) to 10 (worst possible pain) scale. Scores will be collected immediately post-treatment and at the 12 week follow-up visit.
Safety as Evaluated by the Number and Severity of All Reported Adverse Events. 12 weeks post-treatment All adverse will be assessed for frequency and severity from the time of enrollment though the 12 week follow-up visit.
Trial Locations
- Locations (3)
Bowes Dermatology Group
🇺🇸Miami, Florida, United States
Innovation Research Center
🇺🇸Pleasanton, California, United States
Ed Becker, MD
🇺🇸Walnut Creek, California, United States