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

Cedars-Sinai Medical Center logo

Cedars-Sinai Medical Center

Status

Not yet enrolling

Conditions

Fecal Incontinence

Treatments

Device: High Intensity Focused Electromagnetic Stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT07034443
STUDY00003888

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

High Intensity Focused Electromagnetic Stimulation
Experimental group
Description:
This will include all the patients within the study who will be receiving the High Intensity Focused Electromagnetic Stimulation
Treatment:
Device: High Intensity Focused Electromagnetic Stimulation

Trial documents
2

Trial contacts and locations

1

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Central trial contact

Gayane Ovespyan, MPH; Samara Spence, MD

Data sourced from clinicaltrials.gov

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