NCT06316999

Brief Summary

Intestinal ultrasound (IUS) has been studied in the evaluation of inflammatory bowel disease (IBD) and is increasingly used as a non-invasive, easy to use, cost-effective tool for point-of-care to assess disease activity and more recently to predict response to treatment. However, there is a paucity of data on the use of IUS specifically for ulcerative colitis (UC) patients with an ileal pouch-anal anastomosis (IPAA).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2024

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 19, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 4, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 4, 2025

Completed
Last Updated

June 8, 2025

Status Verified

June 1, 2025

Enrollment Period

11 months

First QC Date

February 28, 2024

Last Update Submit

June 4, 2025

Conditions

Ulcerative ColitisPouchitis

Keywords

Ileal Pouch Anal Anastomosis

Outcome Measures

Primary Outcomes (1)

  • Diagnostic accuracy of intestinal ultrasound (IUS) for pouchitis

    compared to gold standard of pouchoscopy with biopsies

    through study completion, an average of 1 year

Study Arms (1)

Patients with Pouchitis

OTHER

Transabdominal and transperineal ultrasounds of the pouch will be performed by an experienced sonographer for each patient and interpreted by a board-certified radiologist specializing in IUS.

Diagnostic Test: Intestinal Ultrasound

Interventions

Intestinal UltrasoundDIAGNOSTIC_TEST

Transabdominal and trans perineal ultrasound of the pouch

Patients with Pouchitis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults (age ≥ 18 years)
  • Diagnosis of ulcerative colitis (UC)
  • Status post ileal pouch anal anastomosis IPAA (completed all stages)

You may not qualify if:

  • Pediatric patients
  • Indeterminate colitis
  • Status post IPAA for familial adenomatous polyposis (FAP)
  • BMI \> 30 kg/m2
  • Pregnant
  • Decompensated Cirrhosis
  • Inability to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Colitis, UlcerativePouchitis

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal DiseasesIleitisEnteritisIleal Diseases

Study Officials

  • Darrell Pardi, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 28, 2024

First Posted

March 19, 2024

Study Start

July 1, 2024

Primary Completion

June 4, 2025

Study Completion

June 4, 2025

Last Updated

June 8, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)