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

NCT ID: NCT07034443

Last Updated: 2025-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2026-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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Fecal Incontinence

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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High Intensity Focused Electromagnetic Stimulation

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Group Type EXPERIMENTAL

High Intensity Focused Electromagnetic Stimulation

Intervention Type DEVICE

Patients will sit on the device, the high intensity for 28 minutes, twice a week for three weeks

Interventions

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High Intensity Focused Electromagnetic Stimulation

Patients will sit on the device, the high intensity for 28 minutes, twice a week for three weeks

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Individuals 18 years old or older are included.
* Patients who have a J pouch reconstruction due to Ulcerative Colitis or IBDU
* Must be at least 1 year out from J pouch surgery
* Have fecal incontinence

Exclusion Criteria

* Any records flagged "break the glass" or "research opt out."
* Pediatric Patients \<18 years of age
* Did not receive a J pouch
* Patients who received a J pouch for any other indication, including but not limited to Crohn's disease, familial adenosis polyposis
* Have active pouchitis
* Have an active fistula
* If reclassified to de novo Crohn's after surgery
* Have implanted metal devices or medical devices
* Pregnant patients
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cedars-Sinai Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Karen Zaghiyan

Colon and Rectal Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Karen Zaghiyan, MD

Role: PRINCIPAL_INVESTIGATOR

Cedar Sinai Medical Center

Locations

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Cedars Sinai Medical Center

Los Angeles, California, United States

Site Status

Countries

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United States

Central Contacts

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Samara Spence, MD

Role: CONTACT

6037323655

Gayane Ovespyan, MPH

Role: CONTACT

3102899224

Facility Contacts

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Karen Zaghiyan, MD

Role: primary

310-289-9224

Gayane Ovsepyan, MPH

Role: backup

3102899224

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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STUDY00003888

Identifier Type: -

Identifier Source: org_study_id

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