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Search / Trial NCT07034443

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

Launched by CEDARS-SINAI MEDICAL CENTER · Jun 19, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Ulcerative Colitis Fecal Incontinence Functional Outcomes High Intensity Focused Electromagnetic Stimulation J Pouch

ClinConnect Summary

This clinical trial is studying how well a treatment called High Intensity Focused Electromagnetic Stimulation (using a device called the Emsella chair) works to improve bowel control and quality of life in people who have ulcerative colitis or a similar condition and have had a surgery called a J pouch (ileal pouch anal anastomosis). This surgery creates a new way for stool to leave the body after the colon is removed. The study will look at how this treatment affects fecal incontinence, which means trouble controlling bowel movements, before, during, and after treatment.

People who might be eligible for this study are adults 18 years or older who have had a J pouch surgery at least one year ago because of ulcerative colitis or indeterminate colitis and currently experience fecal incontinence. Participants should not have active infections or complications in the pouch, other serious bowel conditions, implanted metal or medical devices, or be pregnant. If you join the study, you can expect to receive treatment with the Emsella chair and have your symptoms and quality of life monitored throughout the process. This trial is not yet recruiting, but it aims to help people with bowel control problems after J pouch surgery find new ways to feel better.

Gender

ALL

Eligibility criteria

  • 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

About Cedars Sinai Medical Center

Cedars-Sinai Medical Center is a renowned nonprofit academic medical center located in Los Angeles, California, recognized for its commitment to patient care, research, and education. As a leading institution in clinical trials, Cedars-Sinai harnesses innovative approaches to advance medical knowledge and improve treatment outcomes across various specialties. With a multidisciplinary team of experts, state-of-the-art facilities, and a patient-centered approach, Cedars-Sinai actively contributes to the development of novel therapies and interventions, ensuring the highest standards of clinical research while prioritizing patient safety and ethical considerations.

Locations

Los Angeles, California, United States

Patients applied

0 patients applied

Trial Officials

Karen Zaghiyan, MD

Principal Investigator

Cedar Sinai Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported