Pilot Study of CoolTXT for Non-Invasive Fat Reduction
|ClinicalTrials.gov Identifier: NCT01517646|
Recruitment Status : Completed
First Posted : January 25, 2012
Last Update Posted : June 22, 2017
|Condition or disease||Intervention/treatment|
|Body Fat Disorder||Device: The Zeltiq System|
|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|
|Primary Completion Date :||October 2014|
|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.
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|