NCT03033004

Cryolipolisis for Abdomen and Flank Fat Reduction

Cryolipolisis for Subcutaneous Abodomen and Flank Fat Reduction

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Universidade Cidade de Sao Paulo · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Sixty healthy subjects aged between 18 and 50 will be randomly allocated into three treatment groups: Conventional Cryolipolysis, Contrast Cryolipolysis or Recovery Reperfusion Cryolipolysis. The region will be treated according to the individual need, in the region of abdomen and flanks. Assessments of body composition will be performed at baseline and 30, 60 and 90 days after randomization. Blood collections will also be performed at baseline and between 14 and 21 days after randomization for evaluation of lipid profile and liver function.

Conditions

• Subcutaneous Fat Disorder

Interventions

Type	Name	Description
DEVICE	Conventional Cryolipolysis	Treatment will be a cold exposure of the subcutaneous fat for 60 minutes using the Polarys device. Polarys is a commercially available cryolipolitic device.
DEVICE	Contrast Cryolipolysis	Treatment will consist of a heat exposure of the subcutaneous fat for 10 minutes followed by 60 minutes of cold exposure and 10 minutes of heat exposure again. Cold and heat will be provided by the Polarys device. Polarys is a commercially available cryolipolitic device.
DEVICE	Reperfusion Cryolipolysis	Treatment will be a cold exposure of the subcutaneous fat for 60 minutes followed by 10 minutes of heat exposure using the Polarys device. Polarys is a commercially available cryolipolitic device.

Timeline

• Start date: 2017-01-01
• Primary completion: 2017-08-01
• Completion: 2017-10-01
• First posted: 2017-01-26
• Last updated: 2018-04-20

Locations

1 site across 1 country: Brazil