CoolSculpting and EMS for the Abdomen (NCT03738891) | Clinical Trial Compass
CompletedNot Applicable
CoolSculpting and EMS for the Abdomen
United States50 participantsStarted 2018-11-07
Plain-language summary
Evaluate the use of Electromagnetic Muscle Stimulation as an adjunctive treatment to CoolSculpting.
Who can participate
Age range22 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
* Male and female subjects \> 22 years of age and ≤65 years of age.
* Subject has not had weight change exceeding 5% of body weight in the preceding month.
* Subject agrees to maintain her weight (i.e., within 5%) by not making any major changes in diet or exercise routine during the course of the study.
* Subject agrees to refrain from any new abdominal training exercises during the course of the study.
* BMI ≤ 30 kg/m\^2 as determined at screening.
* Abdominal skin fold thickness 2.0 to 5.0 cm, as measured by caliper below umbilicus.
* Cohort 4 only: Subject participated in protocol ZA18-003 in Cohort 3, and received the CoolSculpting treatment no more than 6 months prior.
* Subject has read and signed a written informed consent form.
Exclusion Criteria
* Subject has had a surgical procedure(s) in the area of intended treatment.
* Subject has had an invasive fat reduction procedure (e.g., liposuction, mesotherapy) in the area of intended treatment.
* Subject has had a non-invasive fat reduction, body contouring and/or skin tightening procedure in the area of intended treatment within the past 12 months.
* Subject has numbness, tingling or other altered sensation in the treatment area.
* Subject needs to administer, or has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month.
* Subject has not had an intrauterine contraceptive device inserted or removed within the past month.
* Sub…
What they're measuring
1
Number of Unanticipated Adverse Device Effects (UADE)
Timeframe: Enrollment through the final 12-week follow-up visit.
2
Number of Participants With Global Aesthetic Improvement Per Independent Physician Review of Photographs Based on Investigator Global Aesthetic Improvement Scale (GAIS-Independent)
Timeframe: Baseline photos will be compared to images collected at the final 12-week post-treatment follow-up visit.