NCT03033004

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

January 10, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 26, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

April 20, 2018

Status Verified

April 1, 2018

Enrollment Period

7 months

First QC Date

January 10, 2017

Last Update Submit

April 19, 2018

Conditions

Subcutaneous Fat Disorder

Outcome Measures

Primary Outcomes (1)

  • Fat layer thickness changes measured by ultrasound

    90 days after randomization

Secondary Outcomes (18)

  • Fat layer thickness changes measured by ultrasound

    30 days after randomization

  • Fat layer thickness changes measured by ultrasound

    60 days after randomization

  • Changes in skin viscoelasticity measured by a cutometer

    30 days after randomization

  • Changes in skin viscoelasticity measured by a cutometer

    60 days after randomization

  • Changes in skin viscoelasticity measured by a cutometer

    90 days after randomization

  • +13 more secondary outcomes

Study Arms (3)

Conventional Cryolipolysis

ACTIVE COMPARATOR

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).

Device: Conventional Cryolipolysis

Contrast Cryolipolysis

ACTIVE COMPARATOR

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).

Device: Contrast Cryolipolysis

Reperfusion Cryolipolysis

ACTIVE COMPARATOR

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).

Device: Reperfusion Cryolipolysis

Interventions

Conventional CryolipolysisDEVICE

Treatment will be a cold exposure of the subcutaneous fat for 60 minutes using the Polarys device. Polarys is a commercially available cryolipolitic device.

Conventional Cryolipolysis
Contrast CryolipolysisDEVICE

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.

Contrast Cryolipolysis
Reperfusion CryolipolysisDEVICE

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.

Reperfusion Cryolipolysis

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro de Estudos e Formação Avançada Ibramed.

Amparo, São Paulo, Brazil

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT, PhD

Study Record Dates

First Submitted

January 10, 2017

First Posted

January 26, 2017

Study Start

January 1, 2017

Primary Completion

August 1, 2017

Study Completion

October 1, 2017

Last Updated

April 20, 2018

Record last verified: 2018-04

Locations

BR(1)