MedTrace Logo

Study of White Adipose Tissue Remodeling by Cryolipolysis in Humans

NCT04819321 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2021-03-26

No results posted yet for this study

Summary

The sample will comprise 12 adult women (aged 18 to 40 years) and overweight (BMI\> 24.9 kg / m² and \<30.0 kg / m²). The experimental design will consist of four assessments. In the first assessments a structured questionnaire will be applied to obtain health and food consumption data, in addition to evaluate anthropometric (weight, height, waist and hip circumference), and collection of blood. In addition, an ultrasound examination, digital photography and biopsy of the subcutaneous WAT, of the abdominal region, will be performed. After 30 day subjects will undergo CoolSculpting treatment(s) in an outpatient clinical setting. The treatment is comprised of timed segments of cooling and heating; a vacuum treatment may include an optional massage. Treatments will be administered according to the User Manual CoolSculpting System. The volunteers will return for the biopsy of the subcutaneous WAT, from the abdominal region, in 3 days after the procedure. In 4º assessment, 60 days after cryolipolysis, all evaluations performed in the first assessment will be repeated and to evaluate overall patient satisfaction for non-invasive fat reduction in CoolSculpting subjects.

Conditions

  • Lipid Metabolism Disorders
  • Metabolic Disease

Interventions

DEVICE

CoolSculpting® System

A treatment is comprised of timed segments of cooling and heating; a vacuum treatment may include an optional massage

Sponsors & Collaborators

  • Allergan Sales, LLC

    collaborator INDUSTRY

  • Federal University of Minas Gerais

    lead OTHER

Principal Investigators

  • Mariele L Silva, Master · Federal University of Minas Gerais

  • Amanda CC Oliveira, Master · Federal University of Minas Gerais

  • Adma M Babetto, Student · Federal University of Minas Gerais

  • Adaliene VM Ferreira, PhD · Federal University of Minas Gerais

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2022-03-01
Completion
2022-03-01
FDA Device
Yes

Countries

  • Brazil

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04819321 on ClinicalTrials.gov