Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2026-01-01 @ 3:39 AM
Study NCT ID:
NCT06882993
Status:
RECRUITING
Last Update Posted:
2025-03-19
First Post:
2025-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of a Minimally Invasive Diagnostic Algorithm in Suspected Crohn's Disease
Sponsor:
Esbjerg Hospital - University Hospital of Southern Denmark
Organization:
Study Overview
Official Title:
Feasibility of a Minimally Invasive Diagnostic Algorithm in Suspected Crohn's Disease - a Prospective Comparison of Pan-Enteric Capsule Endoscopy Versus Ileocolonoscopy Plus MR Enterography or Small-Bowel Capsule Endoscopy
Status:
RECRUITING
Status Verified Date:
2025-03
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:
ANDI-3
Brief Summary:
The goal of this clinical trial is to learn whether a camera pill examination of the whole bowel can be used to diagnose Crohn's disease instead of colonoscopy and a small bowel examination (either MRI or camera pill) in patients aged 18-40 years suspected of having Crohn's disease.
The main question it aims to answer is:
How many patients examined with a camera pill examination of the whole bowel will have a complete examination of the whole bowel and have a diagnosis made without need for any more examinations?
Researchers will compare with patients examined with colonoscopy and a small bowel examination.
Participants will:
* Be examined with either a camera pill examination of the whole bowel, or a colonoscopy and a small bowel examination
* Have their electronic medical records checked to see if a diagnosis has been made
* Have an interview every three months if diagnosed with an inflammatory bowel disease or after a year if no disease was found
The main question it aims to answer is:
How many patients examined with a camera pill examination of the whole bowel will have a complete examination of the whole bowel and have a diagnosis made without need for any more examinations?
Researchers will compare with patients examined with colonoscopy and a small bowel examination.
Participants will:
* Be examined with either a camera pill examination of the whole bowel, or a colonoscopy and a small bowel examination
* Have their electronic medical records checked to see if a diagnosis has been made
* Have an interview every three months if diagnosed with an inflammatory bowel disease or after a year if no disease was found
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: