Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06316999
Status:
RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-02-28
Brief Title:
Intestinal Ultrasound for the Evaluation of Pouchitis and Other Outcomes After Ileal Pouch-Anal Anastomosis
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Utility of Intestinal Ultrasound as a Diagnostic Tool for the Evaluation of Pouchitis and Other Outcomes After Ileal Pouch-Anal Anastomosis A Prospective Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
1 Establish normal sonographic parameters in patients with an IPAA and normal pouch function
2 Evaluate the feasibility of IUS for diagnosing pouchitis and other outcomes and compare its performance with the current gold standard of pouchoscopy with biopsies
1 Establish normal sonographic parameters in patients with an IPAA and normal pouch function
2 Evaluate the feasibility of IUS for diagnosing pouchitis and other outcomes and compare its performance with the current gold standard of pouchoscopy with biopsies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None