Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Ultrasound Cavitation Focused on Located Adiposity

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: NCT02539043
Recruitment Status : Completed
First Posted : September 2, 2015
Last Update Posted : September 2, 2015
Sponsor:
Information provided by (Responsible Party):
Patricia Viana da Rosa, Federal University of Health Science of Porto Alegre

Brief Summary:
The aim of this study is to evaluate the effect of cavitation ultrasound focused on localized adiposity and its effects associated with stereodynamic lymphatic drainage. The investigators aim also to know if this procedure will influence the biochemical profile of the individuals concerned, as well as whether it will be found difference between the group that will receive focused ultrasound cavitation associated with stereodynamic drainage and the group will receive only focused cavitation ultrasound.

Condition or disease Intervention/treatment Phase
Subcutaneous Fat Device: LIPOFOCUS Not Applicable

Show Show detailed description

Layout table for study information
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Active Comparator: Focused ultrasound cavitation: Lipofocus
The first group will receive only the application of focused ultrasound cavitation.
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.
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).




Primary Outcome Measures :
  1. Use of Ultrasound Focused Cavitational reduce the layer of fat in the abdominal area abdominal region. [ Time Frame: Eight weeks ]
  2. Use of Ultrasound Focused Cavitational associated with stereodynamic drainage reduce the layer of fat in the abdominal region. [ Time Frame: Eight weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

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): NCT02539043


Sponsors and Collaborators
Federal University of Health Science of Porto Alegre
Investigators
Layout table for investigator information
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
Layout table for additonal information
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
Keywords provided by Patricia Viana da Rosa, Federal University of Health Science of Porto Alegre:
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight