Intestinal Ultrasound for the Evaluation of Pouchitis and... | NCT06316999

Studies
Intestinal Ultrasound for the Evaluation of Pouchitis and Other Outcomes After Ileal Pouch-Anal Anastomosis

NCT06316999

Sponsor

Mayo Clinic

Status

Completed

Last Update Posted

Jun 8, 2025Actual

Enrollment

55Actual

Phase

Not Applicable

Conditions

Ulcerative Colitis
Pouchitis

Interventions

Intestinal Ultrasound

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2024Actual

Primary Completion Date

Jun 4, 2025Actual

Completion Date

Jun 4, 2025Actual

First Submitted Date

Feb 28, 2024

First Submission Date that Met QC Criteria

Mar 12, 2024

First Posted Date

Mar 19, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 4, 2025

Last Update Posted Date

Jun 8, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

AIMS:

Establish normal sonographic parameters in patients with an IPAA and normal pouch function.
Evaluate the feasibility of IUS for diagnosing pouchitis and other outcomes and compare its performance with the current gold standard of pouchoscopy with biopsies.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

55Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Intestinal Ultrasound	Diagnostic Test	Transabdominal and trans perineal ultrasound of the pouch	Patients with Pouchitis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diagnostic accuracy of intestinal ultrasound (IUS) for pouchitis	compared to gold standard of pouchoscopy with biopsies	through study completion, an average of 1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Darrell Pardi, MD	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic		Rochester	Minnesota	55905	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Submission Tracking

Estimated Results First Submitted Date

Apr 7, 2026

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Apr 7, 2026			Apr 23, 2026	4
May 7, 2026

Condition Browse Module

MeSH Terms

ID	Term
D003093	Colitis, Ulcerative
D019449	Pouchitis

Ancestor Terms

ID	Term
D003092	Colitis
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided