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

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: NCT03545360
Recruitment Status : Unknown
Verified May 2018 by BTL Industries Ltd..
Recruitment status was:  Recruiting
First Posted : June 4, 2018
Last Update Posted : June 4, 2018
Sponsor:
Information provided by (Responsible Party):
BTL Industries Ltd.

Study Description
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Brief Summary:
The study will evaluate safety and efficacy of the BTL-703 device for the non-invasive lipolysis.

Condition or disease Intervention/treatment Phase
Overweight Obesity Device: BTL-703 (Treatment group) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of the BTL-703 Treatment for the Non-invasive Lipolysis
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : January 1, 2019
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Serious adverse events following the treatment [ Time Frame: 5 months ]
    Occurrence of serious adverse events will be followed throughout the whole study.

  2. Photo evaluation [ Time Frame: 5 months ]
    Correct identification of the pre- and post-treatment photos by blinded evaluators.

  3. Subject Satisfaction [ Time Frame: 5 months ]
    Subject Satisfaction Questionnaire will be given to subjects at every follow-up visit.

  4. Therapy discomfort [ Time Frame: 2 months ]
    Subject's discomfort (pain) level after each treatment will be assessed using the Discomfort Questionnaire.


Eligibility Criteria
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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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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): NCT03545360


Contacts
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Contact: Georgi Petkov 32 62 22 52 ext +359 petkov@btlnet.com

Locations
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Bulgaria
Aesthe Clinic Recruiting
Sofia, Bulgaria
Contact: Radina Denkova, MD       aestheclinic@abv.bg   
Principal Investigator: Radina Denkova, MD         
Sponsors and Collaborators
BTL Industries Ltd.
More Information
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Responsible Party: BTL Industries Ltd.
ClinicalTrials.gov Identifier: NCT03545360    
Other Study ID Numbers: BTL-703-001
First Posted: June 4, 2018    Key Record Dates
Last Update Posted: June 4, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Overweight
Body Weight