Effects of Capacitive Radiofrequency at the Dermis and Adipose Tissue
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|ClinicalTrials.gov Identifier: NCT04182542|
Recruitment Status : Completed
First Posted : December 2, 2019
Last Update Posted : September 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|Adiposity Abdominal Obesity||Device: Radiofrequency||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|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.|
|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|
The right side will be treated with 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.
- 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.
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
|Minas Gerais, Uberaba, Brazil|