Muscle DamageNCT06703749
HIFEM and Radiofrequency for Muscular System Function Improvement
A study testing Treatment with BTL-899M and Treatment with BTL-899M with intensities below therapeutic threshold in people with Muscle Damage and Muscle Strength, run by BTL Industries Ltd. at 3 sites in United States.
Trial summary
The goal of this clinical trial is to investigate the effect of the BTL-899M device on muscular system function in adult subjects seeking treatment for improving their muscular system function in the lower extremities. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Muscle Damage, Muscle Strength, Muscle Weakness
- What is being tested?
- Treatment with BTL-899M and Treatment with BTL-899M with intensities below therapeutic threshold
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 3 sitesUnited States
- Study dates
- 22 Apr 2024to Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age 22 years and older
- Voluntarily signed an informed consent form
- BMI ≤ 35 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 pre-procedure therapy regime and the study procedure for improvement of the musculoskeletal system
- Subjects willing and able to maintain their regular (pre-procedure) diet, exercise and therapy regimen without affecting significant change in either direction during study participation
Who cannot join
- Electronic implants (such as cardiac pacemakers, defibrillators, and neurostimulators)
- Metal implants
- Drug pumps
- Malignant tumor
- Pulmonary insufficiency
- Application over muscles in the acute phase of injury
Show all 16Show fewer
- Cardiovascular diseases
- Disturbance of temperature or pain perception
- Hemorrhagic conditions, blood coagulation disorders or anticoagulation therapy
- Septic conditions and empyema
- Acute inflammations
- Systemic or local infection such as osteomyelitis and tuberculosis
- Contagious skin disease
- Elevated body temperature
- Pregnancy, postpartum period, and nursing
- Graves' disease
Trial locations and contacts
3 sites in 1 country.
United States3 sites
The Longevity Lab
Greenwood Village, Colorado, 80111
Saville Spine Institute
Palm Beach Gardens, Florida, 33410
Royal Spine Surgery
Scottsdale, Arizona, 85260
About this study
Official title: Simultaneous Application of HIFEM Procedure and Radiofrequency for Improvement of Muscular System Function
The goal of this clinical trial is to investigate the effect of the BTL-899M device on muscular system function in adult subjects seeking treatment for improving their muscular system function in the lower extremities. The main question it aims to answer is:
Whether the BTL-899M device is effective for muscular system function improvement 3 months posttreatment compared to the sham group, based on the dynamometer measurement.
Researchers will compare a sham group to see if the device is effective.
Participants will complete four treatment visits and two follow-up visits. Their strength will be recorded via a dynamometer.
Read the detailed description
This study will evaluate the clinical efficacy and safety of the BTL-899M device for changes in muscular system function through muscle strength measurement by hand-held dynamometer. The study is a prospective, multi-center, open-label, single-arm study. The subjects will be enrolled and assigned to two groups - active and sham in a 3:1 ratio. All patients will be required to complete four (4) treatment visits receiving the treatment with the study device and two follow-up visits at 1 month and 3 months. The sham group will be treated with 5% of both energies only. The treatment administration phase will consist of four (4) treatments, delivered 5-10 days apart. The applicators of BTL-899M will be applied over the designated area. The device will induce visible muscle contractions along with heating by radiofrequency (RF). Each therapy session will last 30 minutes. At baseline, after the last treatment, and all follow-up visits, the strength measurement of the treated area will be performed by hand-held dynamometer in all subjects. At the last therapy visit, the patients will receive the Subject Satisfaction Questionnaire and Therapy Comfort Questionnaire to fill in. Subject satisfaction questionnaire will be given to the subjects at all follow-up visits. Safety measures will include documentation of adverse events (AE), which will be assessed after each procedure and at all follow-up visits. During the post-procedure visits (at 1-month and 3-month follow-up visits), all subjects will receive the Lifestyle Change Questionnaire to fill in.
- Conditions
- Muscle Damage, Muscle Strength, Muscle Weakness
- Being tested
- Treatment with BTL-899M, Treatment with BTL-899M with intensities below therapeutic threshold
- Keywords
- muscle, muscle impairment, lower extremities, muscle weakness
- Medical subject headings
- Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment with BTL-899MDevice
The treatment administration phase will consist of four (4) treatments, delivered 5-10 days apart. The applicators of BTL-899M will be applied over the designated area. Each therapy session will last 30 minutes. The starting intensity of the radiofrequency energy will be set to 100%. The intensities of both energies will be adjusted according to the patient's feedback.
Treatment with BTL-899M with intensities below therapeutic thresholdDevice
The treatment administration phase will consist of four (4) treatments, delivered 5-10 days apart. The applicators of BTL-899M will be applied over the designated area. Each therapy session will last 30 minutes. The intensities of both energies will be set below the therapeutic threshold.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with BTL-899M | Experimental | Four (4) BTL-899M treatments will be applied to the lower extremities. Receives: Device: Treatment with BTL-899M |
| Treatment with BTL-899M with intensities below therapeutic threshold | Placebo comparator | Four (4) BTL-899M treatments will be applied to the lower extremities, with intensities below therapeutic threshold Receives: Device: Treatment with BTL-899M with intensities below therapeutic threshold |
What is being measured
The primary outcome is the main question the study is designed to answer.
% change from baseline in the muscle strength for the active group vs. sham group at 3 months.
The evaluation of the percentual (%) change in muscle strength in the active group by evaluation of dynamometer score 3 months posttreatment compared to the sham group
Measured: baseline and 3 months
Secondary outcomes (3)
Subject satisfaction as assessed by Subject Satisfaction Questionnaire at 3 months
Subject Satisfaction evaluation based on the Subject Satisfaction Questionnaire administered 3 months posttreatment
Measured: from the first therapy to the 3 months after the last treatment session
Comfort as assessed by Therapy Comfort Questionnaire after the final treatment
Therapy comfort evaluation through the Therapy Comfort Questionnaire administered after the final treatment
Measured: from the first to the last treatment session, assessed up to 40 days
Incidence of Treatment-related Adverse Events
Assessment of safety throughout the course of the study by evaluting the the side effects and AE occurrence throughout the course of the study
Measured: from the first therapy to the end of subject's participation, assessed up to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start22 Apr 2024
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle DamageStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 33 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
- NCT06703749
- Sponsor's protocol ID
- BTL-899_CTUS1100
- Status last verified
- Nov 2024
- First submitted
- 19 Nov 2024
- Last updated
- 25 Nov 2024
- 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 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simultaneous Application of HIFEM Procedure and Radiofrequency for Improvement of Muscular System Function
- ClinicalTrials.gov ID
- NCT06703749
- Acronym / sponsor ID
- BTL-899_CTUS1100
- Conditions
- Muscle Damage, Muscle Strength, Muscle Weakness
- Keywords
- muscle, muscle impairment, lower extremities, muscle weakness
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 33 participants (actual)
- Lead sponsor
- BTL Industries Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 25 Nov 2024 (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 goal of this clinical trial is to investigate the effect of the BTL-899M device on muscular system function in adult subjects seeking treatment for improving their muscular system function in the lower extremities. The main question it aims to answer is:
Whether the BTL-899M device is effective for muscular system function improvement 3 months posttreatment compared to the sham group, based on the dynamometer measurement.
Researchers will compare a sham group to see if the device is effective.
Participants will complete four treatment visits and two follow-up visits. Their strength will be recorded via a dynamometer.
Detailed description
This study will evaluate the clinical efficacy and safety of the BTL-899M device for changes in muscular system function through muscle strength measurement by hand-held dynamometer. The study is a prospective, multi-center, open-label, single-arm study. The subjects will be enrolled and assigned to two groups - active and sham in a 3:1 ratio. All patients will be required to complete four (4) treatment visits receiving the treatment with the study device and two follow-up visits at 1 month and 3 months. The sham group will be treated with 5% of both energies only. The treatment administration phase will consist of four (4) treatments, delivered 5-10 days apart. The applicators of BTL-899M will be applied over the designated area. The device will induce visible muscle contractions along with heating by radiofrequency (RF). Each therapy session will last 30 minutes. At baseline, after the last treatment, and all follow-up visits, the strength measurement of the treated area will be performed by hand-held dynamometer in all subjects. At the last therapy visit, the patients will receive the Subject Satisfaction Questionnaire and Therapy Comfort Questionnaire to fill in. Subject satisfaction questionnaire will be given to the subjects at all follow-up visits. Safety measures will include documentation of adverse events (AE), which will be assessed after each procedure and at all follow-up visits. During the post-procedure visits (at 1-month and 3-month follow-up visits), all subjects will receive the Lifestyle Change Questionnaire to fill in.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment with BTL-899M | Experimental | Device: Treatment with BTL-899MFour (4) BTL-899M treatments will be applied to the lower extremities. |
| Treatment with BTL-899M with intensities below therapeutic threshold | Placebo comparator | Device: Treatment with BTL-899M with intensities below therapeutic thresholdFour (4) BTL-899M treatments will be applied to the lower extremities, with intensities below therapeutic threshold |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 22 years and older
- Voluntarily signed an informed consent form
- BMI ≤ 35 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 pre-procedure therapy regime and the study procedure for improvement of the musculoskeletal system
Key exclusion criteria (16 listed)
- Electronic implants (such as cardiac pacemakers, defibrillators, and neurostimulators)
- Metal implants
- Drug pumps
- Malignant tumor
- Pulmonary insufficiency
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 BTL-899MThe treatment administration phase will consist of four (4) treatments, delivered 5-10 days apart. The applicators of BTL-899M will be applied over the designated area. Each therapy session will last 30 minutes. The starting intensity of the radiofrequency energy will be set to 100%. The intensities of both energies will be adjusted according to the patient's feedback. | Device | Treatment with BTL-899M |
| Treatment with BTL-899M with intensities below therapeutic thresholdThe treatment administration phase will consist of four (4) treatments, delivered 5-10 days apart. The applicators of BTL-899M will be applied over the designated area. Each therapy session will last 30 minutes. The intensities of both energies will be set below the therapeutic threshold. | Device | Treatment with BTL-899M with intensities below therapeutic threshold |
Primary outcome
% change from baseline in the muscle strength for the active group vs. sham group at 3 months.
Time frame: baseline and 3 months
The evaluation of the percentual (%) change in muscle strength in the active group by evaluation of dynamometer score 3 months posttreatment compared to the sham group
3 secondary outcomes
Subject satisfaction as assessed by Subject Satisfaction Questionnaire at 3 months
Time frame: from the first therapy to the 3 months after the last treatment session
Comfort as assessed by Therapy Comfort Questionnaire after the final treatment
Time frame: from the first to the last treatment session, assessed up to 40 days
Incidence of Treatment-related Adverse Events
Time frame: from the first therapy to the end of subject's participation, assessed up to 5 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
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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.
3 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 BTL-899M and Treatment with BTL-899M with intensities below therapeutic threshold in people with Muscle Damage and Muscle Strength, run by BTL Industries Ltd. at 3 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 16 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: under way, not looking for participants, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
% change from baseline in the muscle strength for the active group vs. sham group at 3 months. (time frame: baseline and 3 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 25 Nov 2024.