CoolSculpting and RF for the Submental (CRT)
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03873779|
Recruitment Status : Recruiting
First Posted : March 13, 2019
Last Update Posted : March 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Body Fat Disorder||Device: The ZELTIQ System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Feasibility Study to Explore the Safety and Efficacy of Cryolipolysis Followed by Radiofrequency Treatment for Submental and Submandibular Contouring|
|Actual Study Start Date :||December 18, 2018|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||November 2020|
Experimental: Fat Reduction
The treatments are designed to see if the fat can be reduced in the submental/submandibular area.
Device: The ZELTIQ System
The CoolSculpting machine will be used to perform the treatments.
- Incidence of unanticipated adverse device effects (UADE). It is expected there will be zero UADE's. [ Time Frame: 12-weeks post final treatment ]The primary safety endpoint is measurement of unanticipated adverse device effects. All adverse events reported during and following the treatment will be included in the safety analysis. The frequency and proportion of subjects reporting each type of adverse event will be tabulated by relationship with the treatment and severity of the event.
- Assessment of overall treatment outcome in submental and submandibular area using Subject-graded GAIS (SGAIS) [ Time Frame: 12-weeks post final treatment ]Overall improvement in the targeted area will be assessed by the subject using the GAIS at 12-weeks post-final treatment. The assessment will consist of writing the outcome as: Very much improved; much improved; improved; no change; worse; much worse; very much worse.
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): NCT03873779
|Contact: Tonia N Madereemail@example.com|
|United States, California|
|Innovation Research Center||Recruiting|
|Pleasanton, California, United States, 94588|
|Contact: Lan La 925-474-2501 firstname.lastname@example.org|
|Principal Investigator: Eric Bachelor, MD|
|Study Director:||Kerrie Jiang, NP||Zeltiq Aesthetics|