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Fat Reduction Induced by Magnetic Device - Ultrasonographic Evaluation

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: NCT03537716
Recruitment Status : Withdrawn (It wasn't possible to recruit the desired number of patients.)
First Posted : May 25, 2018
Last Update Posted : September 14, 2020
Sponsor:
Information provided by (Responsible Party):
BTL Industries Ltd.

Tracking Information
First Submitted Date  ICMJE April 19, 2018
First Posted Date  ICMJE May 25, 2018
Last Update Posted Date September 14, 2020
Actual Study Start Date  ICMJE December 15, 2017
Estimated Primary Completion Date May 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 29, 2018)
  • Effectiveness of the device assessed through photographic evaluation [ Time Frame: 13 months ]
    Photographic evaluations with correct identification of pre-treatment images compared to post-treatment images.
  • Effectiveness of the device assessed through change in adipose layer thickness [ Time Frame: 13 months ]
    Change in adipose layer thickness between pre-treatment and post-treatment based on ultrasound measurements
  • Subject's satisfaction [ Time Frame: 13 months ]
    The 5-point Likert scale Subject Satisfaction Questionnaire will be used for an analysis of the subject's opinion of the therapy results. Subjects will be evaluating agreement with three different statements (concerning satisfaction with therapy results and appearance of abdominal area after therapy) by choosing an answer on a scale between 1 (Strongly disagree) and 5 (Strongly agree). Minimally 80% of the treated subjects should report the agreement with all three statements given in the questionnaire (answers "Agree" and "Strongly agree") in order to claim subject's satisfaction with the therapy outcome.
Original Primary Outcome Measures  ICMJE
 (submitted: May 15, 2018)
  • Effectiveness of the device assessed through photographic evaluation [ Time Frame: 13 months ]
    Photographic evaluations with correct identification of pre-treatment images compared to post-treatment images.
  • Effectiveness of the device assessed through change in adipose layer thickness [ Time Frame: 13 months ]
    Change in adipose layer thickness between pre-treatment and post-treatment based on ultrasound measurements
  • Subject's satisfaction [ Time Frame: 13 months ]
    The subject's satisfaction with the therapy results evaluated through the Subject satisfaction questionnaire
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2018)
  • Safety of the device for non-invasive fat disruption [ Time Frame: 13 months ]
    The secondary objective of the study is to determine side effects and adverse events (AE) associated with the treatment of the abdominal area. The occurrence of adverse events will be followed throughout the whole study.
  • Therapy comfort [ Time Frame: 3 months ]
    Therapy comfort will be noted at the last therapy visit.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fat Reduction Induced by Magnetic Device - Ultrasonographic Evaluation
Official Title  ICMJE Safety and Efficacy of Noninvasive Repetitive Pulse Magnetic Stimulation (rPMS) for Fat Disruption of the Abdomen
Brief Summary

The study is a prospective multi-center open-label single-arm study. The subjects will be enrolled and assigned into a single study group. Subjects will be required to complete four (4) treatment visits and four follow-up visits, 1 month, 3, 6 and 12 months after the final treatment.

At the baseline visit photographs of the abdomen will be taken. In addition, adipose/muscle layer thickness will be measured with the ultrasound and the subject's weight will be recorded. In addition, at the last therapy visit, subjects will receive Subject Satisfaction and Therapy Comfort Questionnaires to fill in.

Safety measures will include documentation of adverse events (AE) including subject's experience of pain or discomfort after the procedure. Following each treatment administration and at the follow-up visits, subjects will be checked for immediate post-procedure adverse event assessment.

Post-procedure evaluation (follow-up visits) will be conducted 1 month, 3, 6 and 12 months after the final treatment. An ultrasound imaging and weight measure will be conducted. Also, subject's satisfaction will be noted. During the first (1 month), third (6 months) and last (12 months) follow-up visits, photographs of abdomen will be taken.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Fat Burn
Intervention  ICMJE Device: Treatment with High Intensity Focused ElectroMagnetic system
The treatment administration phase will consist of four (4) treatments, delivered twice a week. The applicator will be applied over the abdomen area. Visible contractions will be induced by the device.
Study Arms  ICMJE Experimental: Treatment Group
Treatment with the investigational device - High Intensity Focused ElectroMagnetic system
Intervention: Device: Treatment with High Intensity Focused ElectroMagnetic system
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: September 10, 2020)
0
Original Actual Enrollment  ICMJE
 (submitted: May 15, 2018)
33
Estimated Study Completion Date  ICMJE June 15, 2019
Estimated Primary Completion Date May 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adult subjects of both genders with unwanted abdominal fat and expressing interest in treatment
  • Age ≥ 22 years
  • Voluntarily signed informed consent form
  • BMI ≤ 30 kg/m2

Exclusion Criteria:

  • Cardiac pacemakers
  • Electronic implants
  • Pulmonary insufficiency
  • Metal implants
  • Drug pumps
  • Haemorrhagic conditions
  • Anticoagulation therapy
  • Heart disorders
  • Malignant tumor
  • Fever
  • Pregnancy
  • Breastfeeding
  • Following recent surgical procedures when muscle contraction may disrupt the healing process
  • Application over menstruating uterus
  • Application over areas of the skin which lack normal sensation
  • Scars, open lesions and wounds at the treatment area
  • Unrepaired abdominal hernia
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03537716
Other Study ID Numbers  ICMJE BTL-Abdomen_001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party BTL Industries Ltd.
Study Sponsor  ICMJE BTL Industries Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account BTL Industries Ltd.
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP