Functional Outcomes in Ulcerative Colitis Patients With Ileal Pouch Anal Anastomosis Treated With High Intensity Focused Electromagnetic Stimulation

Part of paid clinical trials in Los Angeles, California.

Sponsor
Cedars-Sinai Medical Center
Study ID
NCT07034443
Status
Not Yet Recruiting

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Conditions

  • Fecal Incontinence

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • High Intensity Focused Electromagnetic Stimulation — DEVICE
    Patients will sit on the device, the high intensity for 28 minutes, twice a week for three weeks

Study Details

The purpose of this research is to evaluate functional outcomes in patients with Ulcerative Colitis and IBDU who have received an ileal pouch anal anastomosis (IPAA), commonly referred to as a J pouch, after treatment with the Emsella chair. We will specifically look at fecal incontinence and patient health related quality of life outcomes before, during and after course of treatment.

Key Dates

Start date
Jul 1, 2025
Status verified
Jun 2025
Primary completion
Jan 1, 2026
Completion
Jun 1, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: High Intensity Focused Electromagnetic Stimulation
    This will include all the patients within the study who will be receiving the High Intensity Focused Electromagnetic Stimulation

Primary Outcome Measure

Determine if patients have change in overall quality of live, as determined by statistically significant change in Patient Reported Outcomes Measurement Information System 10 Score from baseline [ Time Frame: baseline, 1 month and 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cedars Sinai Medical CenterLos AngelesCalifornia90048
Karen Zaghiyan, MD
[email protected]
310-289-9224
Gayane Ovsepyan, MPH
[email protected]
3102899224
Samara S Spence, MD (SUB_INVESTIGATOR)

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By research site
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