Pilot Study on The Flanks of Asian Patients
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|ClinicalTrials.gov Identifier: NCT01623037|
Recruitment Status : Completed
First Posted : June 19, 2012
Last Update Posted : June 22, 2017
|Condition or disease||Intervention/treatment||Phase|
|Body Fat Disorder||Device: The Zeltiq System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||PILOT STUDY OF NON-INVASIVE FAT LAYER REDUCTION IN THE FLANKS OF ASIAN PATIENTS WITH THE COOLCURVE+ APPLICATOR|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||October 2014|
|Experimental: Fat Reduction||
Device: The Zeltiq System
Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
- Efficacy [ Time Frame: 12 weeks post final treatment ]• Correct identification of pre-treatment vs. 12-week post-treatment images by three blinded independent reviewers.
- Ultrasound Measurements [ Time Frame: 12 weeks post final treatment ]• Reduction in the fat layer thickness, as demonstrated by comparison of pre-treatment and 12-week post-treatment caliper measurements.
- Subject Satisfaction Questionnaire [ Time Frame: 12 weeks post final treatment ]
- Subject satisfaction as assessed by questionnaire administered at 12-week post-treatment.
- Operator feedback on the fit of the device via a questionnaire at treatment visit.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01623037
|China, Hong Kong|
|Hong Kong Dermatology and Laser Centre|
|Central, Hong Kong, China|
|Principal Investigator:||Henry Chan, MD||Hong Kong Dermatology and Laser Centre|