NCT03304925
Unknown
Not Applicable
CoolSculpting the Flanks
Zeltiq Aesthetics7 sites in 1 country320 target enrollmentOctober 25, 2017
ConditionsBody Fat Disorder
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Body Fat Disorder
- Sponsor
- Zeltiq Aesthetics
- Enrollment
- 320
- Locations
- 7
- Primary Endpoint
- Effectiveness endpoint gauged by reduction in fat layer thickness
- Last Updated
- 5 years ago
Overview
Brief Summary
Evaluate the safety and efficacy of non-invasive subcutaneous fat layer reduction in the flanks.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Effectiveness endpoint gauged by reduction in fat layer thickness
Time Frame: Final post-treatment visit
Reduction in fat layer thickness as measured by ultrasound at the final post-treatment visit.
Safety endpoint in relation to adverse events
Time Frame: Final post treatment visit
Measurement of device- or procedure-related adverse events. It is expected there will be zero UADEs
Secondary Outcomes
- Subject survey(Final post-treatment visit)
- Photo review(Final post-treatment visit)
Study Sites (7)
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