NCT02999763

SlimShape Device for Abdominal Fat and Circumference Reduction

Clinical Study to Evaluate the Safety and Efficacy of the SlimShape Device for Abdominal Fat and Circumference Reduction

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Syneron Medical · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Fat Disorder

Interventions

Type	Name	Description
DEVICE	SlimShape	SlimShape radiofrequency treatment to the abdomen

Timeline

• Start date: 2017-01-13
• Primary completion: 2018-05-03
• Completion: 2018-08-07
• First posted: 2016-12-21
• Last updated: 2019-04-18
• Results posted: 2019-04-04

Locations

4 sites across 1 country: United States