Fat BurnNCT03545646
Changes in Abdominal Tissues Induced by Magnetic Device - CT Evaluation
A study testing Treatment with High Intensity Focused ElectroMagnetic system in people with Fat Burn, run by BTL Industries Ltd. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fat Burn
- What is being tested?
- Treatment with High Intensity Focused ElectroMagnetic system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Dec 2017to 15 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Cardiac pacemakers
- Electronic implants
- Pulmonary insufficiency
- Metal implants
- Drug pumps
- Haemorrhagic conditions
Show all 17Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Chicago Cosmetic Surgery and Dermatology
Chicago, Illinois, 60654
Dermatologic Surgery Specialists
Macon, Georgia, 31217
About this study
Official title: 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 computed tomography 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.
Read more
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. Computed tomography and weight measure will be conducted at every follow-up visit. 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.
- Conditions
- Fat Burn
- Being tested
- Treatment with High Intensity Focused ElectroMagnetic system
- Keywords
- Abdominal tissues
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment with High Intensity Focused ElectroMagnetic systemDevice
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 group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Treatment with the investigational device - High Intensity Focused ElectroMagnetic System Receives: Device: Treatment with High Intensity Focused ElectroMagnetic system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of the device assessed through photography evaluation
Photography evaluations with correct identification of pre-treatment images compared to post-treatment images.
Measured: 13 months
Effectiveness of the device assessed through change in adipose/muscle layer thickness
Change in adipose/muscle layer thickness between pre-treatment and post-treatment based on computed tomography measurements.
Measured: 13 months
Subject's satisfaction
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.
Measured: 13 months
Secondary outcomes (2)
Safety of the device for non-invasive fat disruption
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.
Measured: 13 months
Therapy comfort
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2018
- Study start15 Dec 2017
- Primary completion15 May 2019 (estimated)
- Study completion15 Jun 2019 (estimated)
Why it stopped: It wasn't possible to recruit the desired number of patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fat BurnStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- BTL Industries Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03545646
- Sponsor's protocol ID
- BTL-Abdomen_003
- Status last verified
- Sep 2020
- First submitted
- 23 May 2018
- Last updated
- 14 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Noninvasive Repetitive Pulse Magnetic Stimulation (rPMS) for Fat Disruption of the Abdomen
- ClinicalTrials.gov ID
- NCT03545646
- Acronym / sponsor ID
- BTL-Abdomen_003
- Conditions
- Fat Burn
- Keywords
- Abdominal tissues
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: It wasn't possible to recruit the desired number of patients.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- BTL Industries Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Dec 2017 (actual)
- Primary completion
- 15 May 2019 (estimated)
- Study completion
- 15 Jun 2019 (estimated)
- First posted
- 4 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 computed tomography 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. Computed tomography and weight measure will be conducted at every follow-up visit. 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: Treatment with High Intensity Focused ElectroMagnetic systemTreatment with the investigational device - High Intensity Focused ElectroMagnetic System |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (17 listed)
- Cardiac pacemakers
- Electronic implants
- Pulmonary insufficiency
- Metal implants
- Drug pumps
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment with High Intensity Focused ElectroMagnetic systemThe 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. | Device | Treatment Group |
Primary outcome
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.
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 computed tomography 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.
2 secondary outcomes
Safety of the device for non-invasive fat disruption
Time frame: 13 months
Therapy comfort
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment with High Intensity Focused ElectroMagnetic system in people with Fat Burn, run by BTL Industries Ltd. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of the device assessed through photography evaluation (time frame: 13 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2020.