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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up treatment 1, treatment 2, treatment 3, up to 1 month
Awards & highlights
Study Summary
At least 90 female and male subjects, from 6 investigational sites, aged 18-70 seeking non-invasive lipolysis and circumference reduction of abdomen will be enrolled. Eligible subjects will receive 3 bi-weekly treatments (once in 2 weeks) with Trim II hands-free applicator belt according to the study protocol.Study duration for each subject is approximately 6 months (including screening, 3 treatments and 2 follow-up visits at 1 and 3 months post last treatment).
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ treatment 1, treatment 2, treatment 3, up to 1 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~treatment 1, treatment 2, treatment 3, up to 1 month
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Efficacy of the Trim II treatment for lipolysis and abdominal circumference change.
Safety of the Trim II treatment for lipolysis and abdominal circumference change.
Secondary outcome measures
Change in abdominal fat thickness measured by ultrasound imaging (USI) at the 3 months follow-up visit comparing to baseline.
Efficacy of the Trim II treatment for fat and circumference change in abdomen, as assessed by two blinded evaluators
Subject's satisfaction with study treatment at 3 months follow-up visit.
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: treatmentExperimental Treatment1 Intervention
3 bi-weekly treatments
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Who is running the clinical trial?
InMode MD Ltd.Lead Sponsor
23 Previous Clinical Trials
1,295 Total Patients Enrolled
Frequently Asked Questions
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