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Effects of Capacitive Radiofrequency at the Dermis and Adipose Tissue

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04182542
Recruitment Status : Completed
First Posted : December 2, 2019
Last Update Posted : September 4, 2020
Sponsor:
Collaborator:
Universidade Federal do Triangulo Mineiro
Information provided by (Responsible Party):
Andreia Noites, Escola Superior de Tecnologia da Saúde do Porto

Brief Summary:
Noninvasive fat reduction is a rapidly expanding field of cosmetic rejuvenation, as many patients are unwilling to suffer the downtime and healing associated with traditional invasive liposuction. The radiofrequency (RF) device has been shown to be safe and effective for non-invasive fat reduction, as well as cutaneous enhancement and improvement of skin flaccidity (BOISNIC, et al., 2014).

Condition or disease Intervention/treatment Phase
Adiposity Abdominal Obesity Device: Radiofrequency Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Masking Description: The assessor will not know, when analyzing the samples, to which group they belong.
Primary Purpose: Treatment
Official Title: Effects of Capacitive Radiofrequency at the Dermis and Adipose Tissue in the Abdominal Region
Actual Study Start Date : December 2, 2019
Actual Primary Completion Date : April 24, 2020
Actual Study Completion Date : July 31, 2020

Arm Intervention/treatment
Experimental: RF
The right side will be treated with radiofrequency
Device: Radiofrequency
The volunteers will receive radiofrequency (TECAR-BTL® device, with epidermal temperature above 40ºC) in the right infraumbilical abdominal region, with an application time of 10 minutes (2 minutes per applicator area) and the left region will be used as control. A single session will be held. After approximately 30 days of this application the material for histological analysis will be collected during the surgical act, at which point the skin and the subcutaneous tissue of the infraumbilical region are discarded by the surgeon.
Other Name: Radiofrequency treatment

No Intervention: NI
The left side will not receive treatment.



Primary Outcome Measures :
  1. percentage of collagen, elastic fibers and the analysis of the amount and volume of the adipose vacuole [ Time Frame: 30 days ]
    The percentage of collagen, elastic fibers and the analysis of the amount and volume of the adipose vacuole will be marked by the Image J® program and registered in a Microsoft Excel worksheet- For the variables percentage of collagen, elastic fibers, number of fibroblasts and number of adipocytes will be performed the normality test with Shapiro Wilk. The paired t test will be used when data are normal and Wilcoxon when not normal. The differences observed will be considered significant when the probability of rejection of the null hypothesis is less than 0.05.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female submited to abdominal surgery
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women who will undergo plastic abdominoplasty surgery at the Clinical Hospital of the Federal UFTM.

Exclusion Criteria:

  • Sensitive and cognitive deficits
  • Aged less than 18 years
  • Metal implant at the application site
  • Pacemakers
  • Signs of infection
  • Circulatory disorders
  • Neoplasia.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04182542


Locations
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Brazil
Adriana mendonça
Minas Gerais, Uberaba, Brazil
Sponsors and Collaborators
Escola Superior de Tecnologia da Saúde do Porto
Universidade Federal do Triangulo Mineiro
Publications:
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Responsible Party: Andreia Noites, Professor/Investigator, Escola Superior de Tecnologia da Saúde do Porto
ClinicalTrials.gov Identifier: NCT04182542    
Other Study ID Numbers: AN-010
First Posted: December 2, 2019    Key Record Dates
Last Update Posted: September 4, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andreia Noites, Escola Superior de Tecnologia da Saúde do Porto:
Capacitive Radiofrequency
Abdominal Adipose Tissue
Additional relevant MeSH terms:
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Obesity, Abdominal
Obesity
Overnutrition
Nutrition Disorders