NCT02539043

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 2, 2015

Completed
Last Updated

September 2, 2015

Status Verified

August 1, 2015

Enrollment Period

4 months

First QC Date

July 13, 2015

Last Update Submit

September 1, 2015

Conditions

Subcutaneous Fat

Keywords

LipolysisSubcutaneous Fat, Abdominal/metabolismSubcutaneous Fat, Abdominal/ultrasonographyHigh-Intensity Focused Ultrasound Ablation/methodsWaist CircumferencePilot ProjectsSubcutaneous FatHigh-Intensity Focused Ultrasound AblationAdiposity

Outcome Measures

Primary Outcomes (2)

  • Use of Ultrasound Focused Cavitational reduce the layer of fat in the abdominal area abdominal region.

    Eight weeks

  • Use of Ultrasound Focused Cavitational associated with stereodynamic drainage reduce the layer of fat in the abdominal region.

    Eight weeks

Study Arms (2)

Focused ultrasound cavitation: Lipofocus

ACTIVE COMPARATOR

The first group will receive only the application of focused ultrasound cavitation.

Device: LIPOFOCUS

Focused ultrasound and drainage: Lipofocus

ACTIVE COMPARATOR

The second group will receive focused ultrasound cavitation followed by stereodynamic drainage.

Device: LIPOFOCUS

Interventions

LIPOFOCUSDEVICE

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.

Focused ultrasound cavitation: Lipofocus

Eligibility Criteria

Age19 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Cinara LS Lima

    Federal University of Health Science of Porto Alegre

    PRINCIPAL INVESTIGATOR

  • Suélen A Kislowski

    Federal University of Health Science of Porto Alegre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunct Professor

Study Record Dates

First Submitted

July 13, 2015

First Posted

September 2, 2015

Study Start

January 1, 2015

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

September 2, 2015

Record last verified: 2015-08