EMS for Abdominal and Gluteal Muscle Toning (CTP)
|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: NCT03983304|
Recruitment Status : Recruiting
First Posted : June 12, 2019
Last Update Posted : June 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Body Fat Disorder||Device: The ZELTIQ System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Electromagnetic Muscle Stimulation for Abdominal and Gluteal Muscle Toning|
|Estimated Study Start Date :||June 10, 2019|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||November 2021|
Experimental: Fat Reduction
The treatments are designed to see if the fat can be toned in the abdomen and the glute.
Device: The ZELTIQ System
The CoolSculpting machine will be used to perform the treatments.
- Efficacy Endpoint: Subject Satisfaction Questionnaire [ Time Frame: 4-wk follow up visit ]Measurement of subject feeling about body shape, assessed using the Body Satisfaction Scale at the 4-Week follow-up visit.
- Subject Global Aesthetic Improvement Scale (GAIS) [ Time Frame: 4-wk follow up visit ]Subject-graded improvement in the treated area using the Subject Global Aesthetic Scale (SGAIS) at the 4-Week follow-up 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): NCT03983304
|Contact: Tonia N Maderefirstname.lastname@example.org|
|United States, California|
|Innovation Research Center||Active, not recruiting|
|Pleasanton, California, United States, 94588|
|Cosmetic Laser Dermatology||Active, not recruiting|
|San Diego, California, United States, 92121|
|United States, Florida|
|Bowes Dermatology by Riverchase||Recruiting|
|Miami, Florida, United States, 33133|
|Contact: Elizabeth DeKok 305-856-6519 email@example.com|
|Contact: Carla Homez (305) 856 6519 firstname.lastname@example.org|
|Principal Investigator: Leyda Bowes, MD|
|Study Director:||Kerrie Jiang, NP||Zeltiq Aesthetics|