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Changes in Abdominal Tissues Induced by Magnetic Device - MRI 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: NCT03545633
Recruitment Status : Withdrawn (It wasn't possible to recruit the desired number of patients.)
First Posted : June 4, 2018
Last Update Posted : September 14, 2020
Sponsor:
Information provided by (Responsible Party):
BTL Industries Ltd.

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 three follow-up visits, 2 months, 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 magnetic resonance imaging and the subject's weight will be recorded.

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. In addition, at the last therapy visit, subjects will receive Subject Satisfaction and Therapy Comfort Questionnaires to fill in.

Post-procedure evaluation (follow-up visits) will be conducted 2, 6 and 12 months after the final treatment. During those visits, magnetic resonance imaging, photographing and weight measure will be conducted. Subject Satisfaction Questionnaire will be given at every follow-up visit.


Condition or disease Intervention/treatment Phase
Fat Burn Device: Treatment with High Intensity Focused ElectroMagnetic system. Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Noninvasive Repetitive Pulse Magnetic Stimulation (rPMS) for Fat Disruption of the Abdomen
Actual Study Start Date : December 15, 2017
Estimated Primary Completion Date : May 15, 2019
Estimated Study Completion Date : June 15, 2019

Arm Intervention/treatment
Experimental: Treatment Group
Treatment with the investigational device - High Intensity Focused ElectroMagnetic System
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.





Primary Outcome Measures :
  1. Effectiveness of the device assessed through photography evaluation [ Time Frame: 13 months ]
    Photography evaluations with correct identification of pre-treatment images compared to post-treatment images.

  2. Effectiveness of the device assessed through change in adipose/muscle layer thickness [ Time Frame: 13 months ]
    Change in adipose/muscle layer thickness between pre-treatment and post-treatment based on magnetic resonance imaging measurements.

  3. 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.


Secondary Outcome Measures :
  1. 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.


  2. Therapy comfort [ Time Frame: 3 months ]
    Therapy comfort will be noted at the last therapy visit. Subjects will be asked to evaluate the agreement with the statement concerning the conformity of the study treatment. Subjects will be evaluating the agreement by choosing an answer on a scale between 1 (Strongly disagree) and 5 (Strongly agree). Based on a given answers, the therapy comfort will be calculated.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  • 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

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): NCT03545633


Locations
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United States, California
Plastic Surgery Excellence
Beverly Hills, California, United States, 90212
Bulgaria
Paula Fines Center
Sofia, Bulgaria, 1632
Sponsors and Collaborators
BTL Industries Ltd.
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Responsible Party: BTL Industries Ltd.
ClinicalTrials.gov Identifier: NCT03545633    
Other Study ID Numbers: BTL-Abdomen_002
First Posted: June 4, 2018    Key Record Dates
Last Update Posted: September 14, 2020
Last Verified: September 2020
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: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by BTL Industries Ltd.:
Abdominal tissues