Cryolipolisis for Abdomen and Flank Fat Reduction

Universidade Cidade de Sao Paulo

Status: Completed

Conditions: Subcutaneous Fat Disorder

Treatments: Device: Reperfusion Cryolipolysis; Device: Conventional Cryolipolysis; Device: Contrast Cryolipolysis

Study type: Interventional

Funder types: Other

Identifiers

NCT03033004

CAAE: 61499416.5.0000.5490

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy subjects
• Body mass index > 29.9 Kg/m2

Exclusion criteria

• Pregnancy
• Diabetes
• Cancer
• Vascular diseases
• Heart diseases
• Liposuction or other surgical procedures for body contouring
• Active infection
• Wounds
• Paroxysmal cold hemoglobinuria
• Cold urticaria
• Significant weight changes in the past 3 months or during treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups

Conventional Cryolipolysis

Active Comparator group

Description:

Subjects will receive one treatment session of conventional cryolipolisys. Subcutaneous fat tissue will be cooled with the cryolipolitic device for 60 minutes. The treatmente area will be the abdomen and/or flanks according to each patient's needs (pragmatic treatment).

Treatment:

Device: Conventional Cryolipolysis

Contrast Cryolipolysis

Active Comparator group

Description:

Subjects will receive one treatment session of contrast cryolipolisys. Subcutaneous fat tissue will be heated for 10 minutes, cooled for 60 minutes, and heated again for 10 minutes with the cryolipolitic device. The treatmente area will be the abdomen and/or flanks according to each patient's needs (pragmatic treatment).

Treatment:

Device: Contrast Cryolipolysis

Reperfusion Cryolipolysis

Active Comparator group

Description:

Subjects will receive one treatment session of Reperfusion Cryolipolysis. Subcutaneous fat tissue will be cooled with the cryolipolitic device for 60 minutes and heated for 10 minutes. The treatmente area will be the abdomen and/or flanks according to each patient's needs (pragmatic treatment).

Treatment:

Device: Reperfusion Cryolipolysis