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ACTIVE NOT RECRUITING
NCT06703749
NA

HIFEM and Radiofrequency for Muscular System Function Improvement

Sponsor: BTL Industries Ltd.

View on ClinicalTrials.gov

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. 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.

Official title: Simultaneous Application of HIFEM Procedure and Radiofrequency for Improvement of Muscular System Function

Key Details

Gender

All

Age Range

22 Years - Any

Study Type

INTERVENTIONAL

Enrollment

33

Start Date

2024-04-22

Completion Date

2025-06

Last Updated

2024-11-25

Healthy Volunteers

Yes

Interventions

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.

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.

Locations (3)

Royal Spine Surgery

Scottsdale, Arizona, United States

The Longevity Lab

Greenwood Village, Colorado, United States

Saville Spine Institute

Palm Beach Gardens, Florida, United States