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Device
Study To Assess Radiofrequency Diathermocontraction Device For Muscle Stimulation And The Treatment Of Abdominal Fat
N/A
Waitlist Available
Research Sponsored by Cynosure, Inc.
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 30 days follow up.
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing sticky pads that send electrical signals to muscles to help reduce belly fat. It involves healthy adults aged 18 or older who have belly fat. The electric shocks make the muscles contract, which may help in reducing fat. Electrical muscle stimulation (EMS) devices have been advertised to increase muscle strength, decrease body weight and body fat, and improve muscle firmness and tone in healthy individuals.
Eligible Conditions
- Belly Fat
- Electrical Muscle Stimulation
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days follow up.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days follow up.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Subjects Satisfied
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Group BExperimental Treatment1 Intervention
Subjects in Group B may receive up to 8 treatments with the Brera/Med 400 device on their abdomen and/or flanks. Subjects may receive a phone call 1 week (1-7 days) after each treatment to record side effects. Subjects may be asked return for follow up visits at 30 and 90 days post last treatment for efficacy and side effects assessments. Outcome measures will not be taken for subjects enrolled in this group.
Group II: Group AExperimental Treatment1 Intervention
Subjects in Group A will receive up to 8 treatments with the Brera/Med 400 device on their abdomen or flanks. Subjects may receive a phone call 1 week (1-7 days) after each treatment to record side effects. Subjects will return for follow up visits at 30 and 90 days post last treatment for efficacy and side effects assessments.
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Who is running the clinical trial?
Cynosure, Inc.Lead Sponsor
51 Previous Clinical Trials
1,220 Total Patients Enrolled
Jennifer CiviokStudy DirectorDirector of Clinical Development
16 Previous Clinical Trials
476 Total Patients Enrolled