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BTL Emsella Chair Versus Sham for the Treatment of Fecal Incontinence

NCT04138602 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2020-09-03

No results posted yet for this study

Summary

The purpose of this clinical trial is to compare the Emsella Chair to sham and to determine whether electromagnetic technology is effective in the treatment of fecal incontinence. Currently there are no other studies utilizing the Emsella Chair for the treatment of fecal incontinence. Eligible subjects will receive 2 treatments per week for a total of 4 weeks.

Conditions

  • Fecal Incontinence

Interventions

DEVICE

BTL Emsella

Subjects will be asked to sit on the device and the height will be adjusted until the subject's feet are on the floor. The active treatments are individualized, since some subjects will be more sensitive than others. The Emsella Chair will be turned on and the setting gradually increased to the subject's sensory threshold; the maximum sensation the subject can tolerate. The setting will then be decreased slightly and stay unchanged for the remainder of the treatment time. The treatment threshold should be increased with every treatment until the subject reaches 100%.

DEVICE

Sham BTL Emsella

Sham subjects will be seated on the device in the same manner as the active treatment group. The sham treatment will provide some sensation without active HIFEM technology. The programming for the sham treatment will have an amplitude limitation, with the setting below the therapeutic level ( \< 10 % power).

Sponsors & Collaborators

  • William Beaumont Hospitals

    lead OTHER

Principal Investigators

  • Kenneth Peters, MD · Beaumont Hospital-Royal Oak

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2020-09-01
Completion
2020-09-01
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 NCT04138602 on ClinicalTrials.gov