Fat Reduction Induced by Magnetic Device - Ultrasonographic Evaluation
Safety and Efficacy of Noninvasive Repetitive Pulse Magnetic Stimulation (rPMS) for Fat Disruption of the Abdomen
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Burgas, Bulgaria, 8000
- Dermasense Dermatology Clinic
-
-
-
-
New York
-
New York, New York, United States, 10022
- JUVA Skin & Laser Center
-
-
Pennsylvania
-
Langhorne, Pennsylvania, United States, 19047
- Center for SmartLipo and Plastic Surgery
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
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
Treatment with the investigational device - 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
13 months
|
|
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.
|
13 months
|
|
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
|
13 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
13 months
|
|
Therapy comfort
Time Frame: 3 months
|
Therapy comfort will be noted at the last therapy visit.
|
3 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- BTL-Abdomen_001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.