Recruiting

Emsella Chair

Sponsor:

Cedars-Sinai Medical Center

Code:

NCT07034443

Conditions

Fecal Incontinence

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

High Intensity Focused Electromagnetic Stimulation

Study Details

Brief summary:

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.

Conditions

Fecal Incontinence

Study ID

NCT07034443

Start date

Aug 1, 2026

Status verified date

Aug, 2026

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Jul 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

High Intensity Focused Electromagnetic Stimulation

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

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 and Locations

Central contacts

Samara Spence, MD

6037323655samara.spence@cshs.org

Gayane Ovespyan, MPH

3102899224gayane.ovespyan@cshs.org

Locations

Cedars Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Karen Zaghiyan, MD

3102899224karen.zaghiyan@cshs.org

Gayane Ovsepyan, MPH

3102899224gayane.ovsepyan@cshs.org

More Information

Sponsor

Cedars-Sinai Medical Center

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Keywords

  • Ulcerative colitis
  • Fecal Incontinence
  • Functional Outcomes
  • High Intensity Focused Electromagnetic Stimulation
  • J pouch

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cedars-Sinai Medical Center on 2026-08-12.