Pilot Study on The Flanks of Asian Patients
|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.
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|