Functional Outcomes in Ulcerative Colitis Patients With Ileal Pouch Anal Anastomosis Treated With High Intensity Focused Electromagnetic Stimulation
Recruiting · NCT07034443 · Interventional (participants receive a specific treatment) · Lead sponsor: Cedars-Sinai Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
High Intensity Focused Electromagnetic Stimulation
What this trial is 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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed across 1 US state.
- Cedars Sinai Medical Center - Los Angeles, California, United States