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
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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NOT_YET_RECRUITING
NA
20 participants
INTERVENTIONAL
2025-07-01
2026-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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High Intensity Focused Electromagnetic Stimulation
This will include all the patients within the study who will be receiving the High Intensity Focused Electromagnetic Stimulation
High Intensity Focused Electromagnetic Stimulation
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Cedars-Sinai Medical Center
OTHER
Responsible Party
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Karen Zaghiyan
Colon and Rectal Surgeon
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
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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STUDY00003888
Identifier Type: -
Identifier Source: org_study_id
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