Safety and Efficacy of the BTL-703 Treatment for the Non-invasive Lipolysis

June 1, 2018 updated by: BTL Industries Ltd.
The study will evaluate safety and efficacy of the BTL-703 device for the non-invasive lipolysis.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Sofia, Bulgaria
        • Recruiting
        • Aesthe Clinic
        • Principal Investigator:
          • Radina Denkova, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥ 22 years
  • Voluntarily signed informed consent form

Exclusion Criteria:

  • Implanted electronic device such as a cardiac pacemaker, bladder stimulator, spinal cord stimulator or electrodes for a myoelectric prosthesis, etc.
  • Diabetics dependent on insulin or oral hypoglycemic medications
  • Known cardiovascular disease such as arrhythmias, congestive heart failure
  • Cardiac surgeries such as cardiac bypass, heart transplant surgery, pacemakers.
  • Prior surgical interventions for body sculpting of thighs or buttocks such as liposuction
  • Medical, physical or other contraindications for body sculpting/ weight loss
  • Current use of medication known to affect weight levels and/or cause bloating or swelling and for which abstinence during the course of study participation is not safe or medically prudent
  • Any medical condition known to affect weight levels and/or to cause bloating or swelling
  • Active infection, wound or other external trauma to the area to be treated
  • Pregnant, breast feeding, or planning pregnant before the end of the study
  • Serious mental health illness
  • Active or recurrent cancer or current chemotherapy and/or radiation treatment
  • Negative affection to heat

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Treatment Group
Treated group of subjects, serves as its own control
Device: BTL-703 (Treatment group)
Treatment with BTL-703 device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Waist circumference reduction
Time Frame: 5 months
The waist circumference measure will be conducted in accordance to the WHO STEPwise approach to surveillance (2008.) and NHLBI Obesity Education Initiative (2000.) recommendations. The waist circumference after the therapy will be compared to baseline.
5 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serious adverse events following the treatment
Time Frame: 5 months
Occurrence of serious adverse events will be followed throughout the whole study.
5 months
Photo evaluation
Time Frame: 5 months
Correct identification of the pre- and post-treatment photos by blinded evaluators.
5 months
Subject Satisfaction
Time Frame: 5 months
Subject Satisfaction Questionnaire will be given to subjects at every follow-up visit.
5 months
Therapy discomfort
Time Frame: 2 months
Subject's discomfort (pain) level after each treatment will be assessed using the Discomfort Questionnaire.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BTL Industries Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2018

Primary Completion (ANTICIPATED)

December 1, 2018

Study Completion (ANTICIPATED)

January 1, 2019

Study Registration Dates

First Submitted

March 28, 2018

First Submitted That Met QC Criteria

June 1, 2018

First Posted (ACTUAL)

June 4, 2018

Study Record Updates

Last Update Posted (ACTUAL)

June 4, 2018

Last Update Submitted That Met QC Criteria

June 1, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BTL-703-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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