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NCT04819321
Study of White Adipose Tissue Remodeling by Cryolipolysis in Humans
NA trial testing CoolSculpting® System in Lipid Metabolism Disorders in 12 participants. Status unknown.
1 March 2022
Quick facts
| Lead sponsor | Federal University of Minas Gerais |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | health services research |
| Enrollment | 12 |
| Start date | 1 April 2021 |
| Primary completion | 1 March 2022 |
| Estimated completion | 1 March 2022 |
| Sites | 1 location across Brazil |
Drugs / interventions tested
- CoolSculpting® System
Conditions studied
- Lipid Metabolism Disorders — all drugs for Lipid Metabolism Disorders →
- Metabolic Disease — all drugs for Metabolic Disease →
Sponsor
Federal University of Minas Gerais
Who can join
Adults 18 to 40, female only, with Lipid Metabolism Disorders or Metabolic Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04819321
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
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Related trials
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Trials testing the same drug.
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04819321 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Federal University of Minas Gerais
- Last refreshed: 26 March 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04819321.
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