Muscle Tone IncreasedNCT03758690
High-Intensity Focused Electromagnetic (HIFEM) Field Device in Women After Childbirth
A study testing High-Intensity Focused Electromagnetic (HIFEM) Field Device in people with Muscle Tone Increased, run by BTL Industries Ltd. at 2 sites in United States.
Trial summary
Evaluation of use of the High-Intensity Focused Electromagnetic (HIFEM) Field Device in women after childbirth. Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Tone Increased
- What is being tested?
- High-Intensity Focused Electromagnetic (HIFEM) Field Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Oct 2018to 2 Jan 2020
- 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 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Non-breastfeeding women 3-36 months after childbirth
- Voluntarily signed informed consent form
- BMI ≤ 30 kg/m2
- Women of child-bearing potential are required to use birth control measures during the whole duration of the study
- Subjects willing and able to abstain from partaking in any treatments other than the study procedure to promote body contouring during study participation
- Subjects willing and able to maintain her regular (pre-procedure) diet and exercise regimen without effecting significant change in either direction during study participation
Who cannot join
- Cardiac pacemakers
- Implanted defibrillators, implanted neurostimulators
- Electronic implants
- Pulmonary insufficiency
- Metal implants
- Drug pumps
Show all 17Show fewer
- Application in the head area
- Application in the heart area
- Malignant tumor
- Fever
- Pregnancy
- Breastfeeding
- Following recent surgical procedures when muscle contraction may disrupt the healing process
- Application over areas of the skin which lack normal sensation
- Scars, open lesions and wounds at the treatment area
- Unrepaired abdominal hernia
- Patients after Cesarean section delivery
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Chicago Cosmetic Surgery and Dermatology
Chicago, Illinois, 60654
Skin Care Physicians of Georgia
Macon, Georgia, 31217
About this study
Official title: Efficacy of Abdominal Treatment With High-Intensity Focused Electromagnetic (HIFEM) Field Device in Women After Childbirth
Evaluation of use of the High-Intensity Focused Electromagnetic (HIFEM) Field Device in women after childbirth.
- Conditions
- Muscle Tone Increased
- Being tested
- High-Intensity Focused Electromagnetic (HIFEM) Field Device
- Medical subject headings
- Muscle Hypertonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Intensity Focused Electromagnetic (HIFEM) Field DeviceDevice
The High-Intensity Focused Electromagnetic (HIFEM) Field device will be applied.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Treatment with the investigational device - High-Intensity Focused Electromagnetic (HIFEM) Field Device Receives: Device: High-Intensity Focused Electromagnetic (HIFEM) Field Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of the device for abdominal toning according to MRI images
Evaluation of MRI images before and after the therapy procedure.
Measured: 7 months
Effectiveness of the device for abdominal toning according to waist circumference measurements
Evaluation of waist circumference measurements (in centimeters).
Measured: 7 months
Secondary outcomes (2)
Subject's satisfaction with study treatment: Questionnaire
Subject's satisfaction with the therapy results evaluated through the Subject Satisfaction Questionnaire. The 7-point Likert scale Subject Satisfaction Questionnaire will be used for an analysis of the subject's opinion of the therapy results.
Measured: 7 months
Determination of side effects and adverse events (AE) associated with the study device.
The occurrence of side effects and adverse events will be followed throughout the whole study
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start25 Oct 2018
- Primary completion13 Aug 2019
- Study completion2 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle Tone IncreasedStudies 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
- 10 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
- NCT03758690
- Sponsor's protocol ID
- BTL-After Childbirth
- Status last verified
- May 2020
- First submitted
- 26 Nov 2018
- Last updated
- 27 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Abdominal Treatment With High-Intensity Focused Electromagnetic (HIFEM) Field Device in Women After Childbirth
- ClinicalTrials.gov ID
- NCT03758690
- Acronym / sponsor ID
- BTL-After Childbirth
- Conditions
- Muscle Tone Increased
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- BTL Industries Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Oct 2018 (actual)
- Primary completion
- 13 Aug 2019 (actual)
- Study completion
- 2 Jan 2020 (actual)
- First posted
- 29 Nov 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.
Evaluation of use of the High-Intensity Focused Electromagnetic (HIFEM) Field Device in women after childbirth.
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: High-Intensity Focused Electromagnetic (HIFEM) Field DeviceTreatment with the investigational device - High-Intensity Focused Electromagnetic (HIFEM) Field Device |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Non-breastfeeding women 3-36 months after childbirth
- Voluntarily signed informed consent form
- BMI ≤ 30 kg/m2
- Women of child-bearing potential are required to use birth control measures during the whole duration of the study
- Subjects willing and able to abstain from partaking in any treatments other than the study procedure to promote body contouring during study participation
Key exclusion criteria (17 listed)
- Cardiac pacemakers
- Implanted defibrillators, implanted neurostimulators
- Electronic implants
- Pulmonary insufficiency
- Metal implants
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 |
|---|---|---|
| High-Intensity Focused Electromagnetic (HIFEM) Field DeviceThe High-Intensity Focused Electromagnetic (HIFEM) Field device will be applied. | Device | Treatment Group |
Primary outcome
Effectiveness of the device for abdominal toning according to MRI images
Time frame: 7 months
Evaluation of MRI images before and after the therapy procedure.
Effectiveness of the device for abdominal toning according to waist circumference measurements
Time frame: 7 months
Evaluation of waist circumference measurements (in centimeters).
2 secondary outcomes
Subject's satisfaction with study treatment: Questionnaire
Time frame: 7 months
Determination of side effects and adverse events (AE) associated with the study device.
Time frame: 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2020.
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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 High-Intensity Focused Electromagnetic (HIFEM) Field Device in people with Muscle Tone Increased, 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 6 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: finished, as of the sponsor's last update on 27 May 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 for abdominal toning according to MRI images (time frame: 7 months). The study lists 2 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 27 May 2020.