Pilot Study of CoolTXT for Non-Invasive Fat Reduction
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01517646|
Recruitment Status : Completed
First Posted : January 25, 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 :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of CoolTXT for Non-Invasive Fat Reduction|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||October 2014|
|No Intervention: Fat Reduction||
Device: The Zeltiq System
Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
- Efficacy Assessment through Ultrasound Measurements [ Time Frame: 16 weeks post final treatment ]
The primary endpoint will be analyzed by percent reduction in fat layer thickness, as measured by ultrasound.
• Safety endpoint: incidence of device- or procedure-related adverse events. Acceptance criteria - zero incidences of UADEs.
- Outcome Measured by Photo Review and Subject Satisfaction Questionnaire [ Time Frame: 16 weeks post final treatment ]
- Comparison of pre- and 16-week post final treatment photographs of the treatment area(s).
- Subject satisfaction as assessed by questionnaires administered at 16 weeks post final treatment.
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): NCT01517646
|Canada, British Columbia|
|Arbutus Laser Centre|
|Vancouver, British Columbia, Canada, V6J IZ6|
|Principal Investigator:||Gerald Boey, MD||Arbutus Laser Centre|