NCT04182542

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

November 26, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 2, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

December 2, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
Last Updated

September 4, 2020

Status Verified

September 1, 2020

Enrollment Period

5 months

First QC Date

November 26, 2019

Last Update Submit

September 3, 2020

Conditions

AdiposityAbdominal Obesity

Keywords

Capacitive RadiofrequencyAbdominal Adipose Tissue

Outcome Measures

Primary Outcomes (1)

  • percentage of collagen, elastic fibers and the analysis of the amount and volume of the adipose vacuole

    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.

    30 days

Study Arms (2)

RF

EXPERIMENTAL

The right side will be treated with radiofrequency

Device: Radiofrequency

NI

NO INTERVENTION

The left side will not receive treatment.

Interventions

RadiofrequencyDEVICE

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.

Also known as: Radiofrequency treatment
RF

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale submited to abdominal surgery
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adriana mendonça

Minas Gerais, Uberaba, Brazil

Location

Related Publications (3)

  • Belenky I, Margulis A, Elman M, Bar-Yosef U, Paun SD. Exploring channeling optimized radiofrequency energy: a review of radiofrequency history and applications in esthetic fields. Adv Ther. 2012 Mar;29(3):249-66. doi: 10.1007/s12325-012-0004-1. Epub 2012 Feb 29.

    PMID: 22382873BACKGROUND

  • Boisnic S, Divaris M, Nelson AA, Gharavi NM, Lask GP. A clinical and biological evaluation of a novel, noninvasive radiofrequency device for the long-term reduction of adipose tissue. Lasers Surg Med. 2014 Feb;46(2):94-103. doi: 10.1002/lsm.22223.

    PMID: 24535760BACKGROUND

  • Krueger N, Levy H, Sadick NS. Safety and efficacy of a new device combining radiofrequency and low-frequency pulsed electromagnetic fields for the treatment of facial rhytides. J Drugs Dermatol. 2012 Nov;11(11):1306-9.

    PMID: 23135079BACKGROUND

MeSH Terms

Conditions

ObesityObesity, Abdominal

Interventions

Pulsed Radiofrequency Treatment

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRadiofrequency TherapyRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The assessor will not know, when analyzing the samples, to which group they belong.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor/Investigator

Study Record Dates

First Submitted

November 26, 2019

First Posted

December 2, 2019

Study Start

December 2, 2019

Primary Completion

April 24, 2020

Study Completion

July 31, 2020

Last Updated

September 4, 2020

Record last verified: 2020-09

Locations

BR(1)