Combination Treatment With BTL-899 and HPM-6000UF Devices

Recruiting at 2 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: BTL Industries Ltd.

Disqualifiers: Cardiovascular diseases, Malignant tumor, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: 6 weeks

39 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial uses two devices to help elderly patients strengthen their core and pelvic muscles without surgery. The devices make the muscles contract, similar to exercising, which can improve muscle strength and quality of life.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, you must not undergo any other treatments on your abdomen and pelvic floor during the study.

Eligibility Criteria

Inclusion Criteria

Healthy male or female subjects aged 60 years or older (postmenopause when female)

BMI ≤35kg/m2 seeking treatment for strengthening their pelvic floor or abdominal muscles

Subjects should be able to understand the investigative nature of the treatment, the possible benefits and side effects, and must sign the Informed Consent Form.

Exclusion Criteria

Hemorrhagic conditions

You have an electronic implant like a pacemaker, defibrillator, or neurostimulator.

You have metal implants in the area being treated.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive BTL-899 and HPM-6000UF device treatments for muscle strengthening

6 weeks

7 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

2 visits (in-person)

Treatment Details

Interventions

• BTL-899
• HPM-6000UF

Participant Groups

Group I: BTL-899; HPM-6000UF Treatments Experimental Treatment 1 Intervention

The two devices will be used separately in two different treatments. However one treatment visit can comprise both treatments. The BTL-899 will be applied over the abdomen, and the device will induce visible muscle contractions along with mild heating of the muscles. Four (4) treatments once a week will be delivered. The HPM-6000UF device will induce pelvic floor muscle contractions. Six (6) treatments 2-4 days apart will be delivered.

Who Is Running the Clinical Trial?

BTL Industries Ltd.

Lead Sponsor

Trials

59

Recruited

2,000+