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

NCT05537181 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2023-01-27

No results posted yet for this study

Summary

This study will evaluate the clinical efficacy of the BTL-899 and HPM-6000UF devices in combination for non-invasive strengthening of the core muscles and overall improvement in quality of life in elderly patients.

Conditions

  • Pelvic Floor Disorders

Interventions

DEVICE

BTL-899; HPM-6000UF Treatments

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.

Sponsors & Collaborators

  • BTL Industries Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-04
Primary Completion
2023-03-31
Completion
2023-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05537181 on ClinicalTrials.gov