Muscle Tone IncreasedNCT04426526
HIFEM for Arms, Lower Limbs, and Oblique Muscles
A study testing BTL 799-2 in people with Muscle Tone Increased, run by BTL Industries Ltd. at 2 sites in United States.
Trial summary
Evaluation of HIFEM treatments for strengthening and toning of arms, lower limbs and oblique muscles. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Muscle Tone Increased
- What is being tested?
- BTL 799-2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 May 2019to 8 Dec 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 19Show fewer
- Application in the head area
- Application in the heart area
- Malignant tumor
- Injured or otherwise impaired muscles
- Fever
- Pregnancy
- Sensitivity or allergy to latex
- 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
Plastic Surgical Associates
Fort Collins, Colorado, 80525
Juva Skin & Laser Center
New York, New York, 11377
About this study
Official title: Efficacy of HIFEM Treatments for Strengthening and Toning of Arms, Lower Limbs and Oblique Muscles
Evaluation of HIFEM treatments for strengthening and toning of arms, lower limbs and oblique muscles.
Read the detailed description
This study will evaluate the clinical efficacy and safety of the high power magnet system for toning and strengthening of arm, lower limb and oblique muscles. The study is a prospective multi-center open-label four-arm study.
- Conditions
- Muscle Tone Increased
- Being tested
- BTL 799-2
- Keywords
- muscle strengthening, muscle tone
- Medical subject headings
- Muscle Hypertonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BTL 799-2Device
High power magnet system
| Study group | Role | What they receive |
|---|---|---|
| Biceps circumference reduction | Experimental | This arm will evaluate the clinical efficacy and safety of the high power magnet system for toning and strengthening of biceps brachii. Receives: Device: BTL 799-2 |
| Triceps circumference reduction | Experimental | This arm will evaluate the clinical efficacy and safety of the high power magnet system for toning and strengthening of triceps brachii. Receives: Device: BTL 799-2 |
| Lower limb circumference reduction | Experimental | This arm will evaluate the clinical efficacy and safety of the high power magnet system for toning and strengthening of muscles in lower limbs. Receives: Device: BTL 799-2 |
| Oblique muscles toning | Experimental | This arm will evaluate the clinical efficacy and safety of the high power magnet system for toning and strengthening of oblique muscles. Receives: Device: BTL 799-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in adipose and muscle tissue measured via ultrasound imaging
To determine the effectiveness of the device for strengthening and toning of arms, lower limbs and oblique muscles through changes in surrounding tissues, measured via ultrasound imaging. Using the obtained images, change in adipose and muscular tissues before and after the therapy sessions will be compared for every participant according to the study phase.
Measured: 7 months
Secondary outcomes (2)
Patient's satisfaction measured via questionnaires
To determine the patient's satisfaction with study treatment for non-invasive strengthening and toning of arms, lower limbs and oblique muscles.The 5-point Likert scale Satisfaction questionnaire will be used to evaluate the participant's satisfaction with the therapy outcome where the level of agreement between "strongly agree" and "strongly disagree" should indicate the participant's satisfaction with the therapy.
Measured: 7 months
Incidence Of Treatment-Related Adverse Events
To determine side effects and adverse events (AE) associated with the BTL 799-2 treatment of the arms, lower limbs and oblique muscles. Safety outcomes will include an evaluation of the treatment area to assess and evaluate the following:
- Muscle pain
- Temporary muscle spasm
- Temporary joint or tendon pain
- Local erythema or skin redness
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 posted11 Jun 2020
- Study start8 May 2019
- Primary completion30 Apr 2020
- Study completion8 Dec 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 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
- NCT04426526
- Sponsor's protocol ID
- BTL-799_600
- Status last verified
- Jan 2021
- First submitted
- 22 May 2020
- Last updated
- 13 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of HIFEM Treatments for Strengthening and Toning of Arms, Lower Limbs and Oblique Muscles
- ClinicalTrials.gov ID
- NCT04426526
- Acronym / sponsor ID
- BTL-799_600
- Conditions
- Muscle Tone Increased
- Keywords
- muscle strengthening, muscle tone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- BTL Industries Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 May 2019 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 8 Dec 2020 (actual)
- First posted
- 11 Jun 2020 (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 HIFEM treatments for strengthening and toning of arms, lower limbs and oblique muscles.
Detailed description
This study will evaluate the clinical efficacy and safety of the high power magnet system for toning and strengthening of arm, lower limb and oblique muscles. The study is a prospective multi-center open-label four-arm study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Biceps circumference reduction | Experimental | Device: BTL 799-2This arm will evaluate the clinical efficacy and safety of the high power magnet system for toning and strengthening of biceps brachii. |
| Triceps circumference reduction | Experimental | Device: BTL 799-2This arm will evaluate the clinical efficacy and safety of the high power magnet system for toning and strengthening of triceps brachii. |
| Lower limb circumference reduction | Experimental | Device: BTL 799-2This arm will evaluate the clinical efficacy and safety of the high power magnet system for toning and strengthening of muscles in lower limbs. |
| Oblique muscles toning | Experimental | Device: BTL 799-2This arm will evaluate the clinical efficacy and safety of the high power magnet system for toning and strengthening of oblique muscles. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (19 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 |
|---|---|---|
| BTL 799-2High power magnet system | Device | Biceps circumference reduction, Lower limb circumference reduction, Oblique muscles toning, Triceps circumference reduction |
Primary outcome
Changes in adipose and muscle tissue measured via ultrasound imaging
Time frame: 7 months
To determine the effectiveness of the device for strengthening and toning of arms, lower limbs and oblique muscles through changes in surrounding tissues, measured via ultrasound imaging. Using the obtained images, change in adipose and muscular tissues before and after the therapy sessions will be compared for every participant according to the study phase.
2 secondary outcomes
Patient's satisfaction measured via questionnaires
Time frame: 7 months
Incidence Of Treatment-Related Adverse Events
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 13 Jan 2021.
Related trials for Muscle Tone Increased
Recruiting
Intrathecal Baclofen and Pediatric Dystonia
Dystonic Cerebral Palsy
RecruitingPhase 4
Individualised Cryoneurolysis to Treat Pain in the Context of Spasticity in the Upper and Lower Extremities
Centreal Neurological Condition, Acquired Brain Injury (Including Stroke)
Not yet recruitingEarly Phase 1
Early Botulinum Toxin for Muscle Stiffness Reduction in First-Time Stroke Patients: Improving Recovery and Independence
Spasticity, Stroke
RecruitingPhase 2
Extracorporeal Shockwave Therapy as an Additional Treatment for Spasticity Secondary to Spinal Cord Injury
Spinal Cord Injury, Spasticity
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
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 BTL 799-2 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 5 inclusion and 19 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 13 Jan 2021. 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?
Changes in adipose and muscle tissue measured via ultrasound imaging (time frame: 7 months). 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 13 Jan 2021.