Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06654128
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-21
Brief Title:
The Yield of Artificial Intelligence GI Genius in Lynch Syndrome - a Randomized Tandem-colonoscopy Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Yield of Artificial Intelligence GI Genius in Lynch Syndrome - a Randomized Tandem-colonoscopy Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
We aim to investigate the incremental detection rate of polyps using AI- assisted colonoscopy compared with high-definition white-light endoscopy HD-WLE
We will conduct a single-center randomized tandem colonoscopy trial of patients with Lynch syndrome with and without AI Patients will undergo tandem colonoscopy the second colonoscopy with either HD-WLE or an AI- assisted device
We will conduct a single-center randomized tandem colonoscopy trial of patients with Lynch syndrome with and without AI Patients will undergo tandem colonoscopy the second colonoscopy with either HD-WLE or an AI- assisted device
Detailed Description:
We will include patients with a known pathogenic variant PV likely PV in one of the MMR genes who are undergoing endoscopic screening and surveillance in our institute Patients will undergo a first colonoscopy with HD-WLE and will be randomized at 11 ratio to undergo a second colonoscopy with either HD-WLE or an AI- assisted device All visualized polyps will be removed and size histology and numbers of polyps detected on each exam will be recorded We will evaluate the adenoma detection rate and polyp detection rate in each arm and the number of adenomas polyps in each arm
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None