SlimShape Device for Abdominal Fat and Circumference Reduction
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|ClinicalTrials.gov Identifier: NCT02999763|
Recruitment Status : Recruiting
First Posted : December 21, 2016
Last Update Posted : January 5, 2017
Prospective, one-arm, baseline-controlled, clinical study for the evaluation of the SlimShape device for non-invasive abdominal fat and circumference reduction.
Study subjects will undergo SlimShape treatments on the abdominal area.
|Condition or disease||Intervention/treatment||Phase|
|Fat Disorder||Device: SlimShape||Not Applicable|
The objective of this trial is to evaluate the safety and efficacy of the SlimShape device utilizing the SlimShape Applicator Belt for abdominal non-invasive fat and circumference reduction. Eligible subjects will receive up to 3 bi-weekly treatments (2 weeks interval) with the SlimShape device utilizing the SlimShape Applicator Belt according to the study protocol.
The subject will return for 3 follow up visits: four weeks (4wk FU), eight weeks (8wk FU) and 12 weeks (12wk FU) after the last treatment.
Each subject will be enrolled for total expected study duration of up to 16 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Study to Evaluate the Safety and Efficacy of the SlimShape Device for Abdominal Fat and Circumference Reduction|
|Study Start Date :||January 2017|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
Experimental: Abdominal fat reduction treatment
SlimShape treatments will be administered for up to 3 sessions to the abdomen of all study participants.
SlimShape radiofrequency treatment to the abdomen
- Reduction in fat thickness at final follow-up compared to baseline [ Time Frame: Baseline and 12 weeks follow-up ]Abdominal fat reduction, measured by ultrasound and caliper, post SlimShape treatments at 12 weeks follow-up (12wk FU) compared to baseline
- Reduction in fat thickness after treatments compared to baseline [ Time Frame: Baseline and 4 and 8 weeks follow-up ]Abdominal fat reduction, measured by ultrasound and caliper, post SlimShape treatments at 4 and 8 weeks follow-up after final treatment compared to baseline
- Reduction in abdominal circumference after treatments compared to baseline [ Time Frame: Baseline and at 4 weeks, 8 weeks and 12 weeks follow-up ]Reduction in abdominal circumference, measured by calibrated measuring tape, at 4 and 8 weeks follow-up after final treatment compared to baseline
- Safety of SlimShape fat reduction treatments by adverse event reporting [ Time Frame: Baseline through study duration of 16 weeks ]Adverse event description, severity, intervention and outcome reporting
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): NCT02999763
|Contact: Shlomit Mann, MScemail@example.com|
|United States, California|
|Laser & Skin Surgery Medical Group, Inc||Recruiting|
|Sacramento, California, United States, 95816|
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|Syneron Candela Institute for Education Clinic||Recruiting|
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|New York, New York, United States, 10003|
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|Laser & Skin Surgery Center of New York||Recruiting|
|New York, New York, United States, 10016|
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|Study Director:||Ruthie Amir, MD||Syneron Medical|