HIFEM and Radiofrequency for Muscular System Function Improvement

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Muscle Weakness; Muscle Strength; Muscle Damage
• Intervention / Treatment: Device: Treatment with BTL-899M; Device: Treatment with BTL-899M with intensities below therapeutic threshold

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 Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85260
      • Royal Spine Surgery
  • Colorado
    • Greenwood Village, Colorado, United States, 80111
      • The Longevity Lab
  • Florida
    • Palm Beach Gardens, Florida, United States, 33410
      • Saville Spine Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment with BTL-899M; Four (4) BTL-899M treatments will be applied to the lower extremities.	Device: Treatment with BTL-899M; 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.
Placebo Comparator: Treatment with BTL-899M with intensities below therapeutic threshold; Four (4) BTL-899M treatments will be applied to the lower extremities, with intensities below therapeutic threshold	Device: Treatment with BTL-899M with intensities below therapeutic threshold; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
% 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	baseline and 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject satisfaction as assessed by Subject Satisfaction Questionnaire at 3 months	Subject Satisfaction evaluation based on the Subject Satisfaction Questionnaire administered 3 months posttreatment	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	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	from the first therapy to the end of subject's participation, assessed up to 5 months

Collaborators and Investigators

• Sponsor: BTL Industries Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: November 19, 2024
• First Submitted That Met QC Criteria: November 21, 2024
• First Posted (Estimated): November 25, 2024

Study Record Updates

• Last Update Posted (Estimated): November 25, 2024
• Last Update Submitted That Met QC Criteria: November 21, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: muscle weakness; muscle; lower extremities; muscle impairment
• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Manifestations; Pathologic Processes; Muscle Weakness; Paresis
• Other Study ID Numbers: BTL-899_CTUS1100

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No