Effects of Ultrasound Cavitation Focused on Located Adiposity
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ClinicalTrials.gov Identifier: NCT02539043 |
Recruitment Status :
Completed
First Posted : September 2, 2015
Last Update Posted : September 2, 2015
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Condition or disease | Intervention/treatment | Phase |
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Subcutaneous Fat | Device: LIPOFOCUS | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 28 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Effects of Ultrasound Cavitation Focused on Located Adiposity: Pilot Study |
Study Start Date : | January 2015 |
Actual Primary Completion Date : | May 2015 |
Actual Study Completion Date : | May 2015 |
Arm | Intervention/treatment |
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Active Comparator: Focused ultrasound cavitation: Lipofocus
The first group will receive only the application of focused ultrasound cavitation.
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Device: LIPOFOCUS
In cavitation focused ultrasound procedure for reduction of localized abdominal fat, the parameters will be used: maximum power of 8 Watts at a frequency of 1 Megahertz (MHz), and the transducer is used in a timely manner by performing a sweep of the area by 03 times, at random. |
Active Comparator: Focused ultrasound and drainage: Lipofocus
The second group will receive focused ultrasound cavitation followed by stereodynamic drainage.
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Device: LIPOFOCUS
In cavitation focused ultrasound procedure for reduction of localized abdominal fat, the parameters will be used: maximum power of 8 Watts at a frequency of 1 MHz, and the transducer is used in a timely manner by performing a sweep of the area by 03 times, at random . The procedure is followed by stereodynamic drainage, where it will be used a printhead comprising three ERAs (effective radiation area) of 15 Watt each time this procedure is calculated through the area (size of the area to be treated) divided by ERA (cm² head size). |
- Use of Ultrasound Focused Cavitational reduce the layer of fat in the abdominal area abdominal region. [ Time Frame: Eight weeks ]
- Use of Ultrasound Focused Cavitational associated with stereodynamic drainage reduce the layer of fat in the abdominal region. [ Time Frame: Eight weeks ]
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Ages Eligible for Study: | 19 Years to 49 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion criteria:
- Females, showing adiposity located in the abdominal area;
- Body Mass Index values are within normal values, 18.5 kg / m2 and 24.9 kg / m2;
- Patients must agree and sign the consent form and clarified.
Exclusion criteria:
- Individuals who contraceptive hormone therapy was changed for less than 4 weeks of starting treatment;
- Showing as lower skinfold to 2 cm;
- Making use of anti-dyslipidemic drugs;
- Present areas of hypoesthesia at the injection site;
- Having inflammation or infection in the region to be treated;
- Woman in pregnancy or breastfeeding;
- With clinical history of malignancies;
- Who have metal implants or cardiac pacemaker;
- Presenting coagulation disorders or making use of medications that alter blood clotting;
- Patients with osteoporosis and / or diabetes mellitus.
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): NCT02539043
Principal Investigator: | Cinara LS Lima | Federal University of Health Science of Porto Alegre | |
Principal Investigator: | Suélen A Kislowski | Federal University of Health Science of Porto Alegre |
Responsible Party: | Patricia Viana da Rosa, Adjunct Professor, Federal University of Health Science of Porto Alegre |
ClinicalTrials.gov Identifier: | NCT02539043 |
Other Study ID Numbers: |
36341214.3.00005345 |
First Posted: | September 2, 2015 Key Record Dates |
Last Update Posted: | September 2, 2015 |
Last Verified: | August 2015 |
Lipolysis Subcutaneous Fat, Abdominal/metabolism Subcutaneous Fat, Abdominal/ultrasonography High-Intensity Focused Ultrasound Ablation/methods Waist Circumference |
Pilot Projects Subcutaneous Fat High-Intensity Focused Ultrasound Ablation Adiposity |
Obesity Overweight Overnutrition Nutrition Disorders Body Weight |