Ignite Creation Date:
2025-12-26 @ 10:16 PM
Ignite Modification Date:
2026-01-22 @ 8:28 AM
Study NCT ID:
NCT04032912
Status:
COMPLETED
Last Update Posted:
2021-03-24
First Post:
2019-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Non-Optical Resect and Discard Study (NORD)
Sponsor:
Centre hospitalier de l'Université de Montréal (CHUM)
Organization:
Study Overview
Official Title:
Eliminating the Need for Conventional Histopathological Assessment of Diminutive Colon Polyps - The Non-Optical Resect and Discard Study (NORD)
Status:
COMPLETED
Status Verified Date:
2018-04
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:
NORD
Brief Summary:
Eliminating the need for conventional histopathological assessment of diminutive colon polyps - The Non-Optical Resect and Discard (NORD) study
Detailed Description:
Implementation of this approach by community-based gastroenterologists has failed to reach the required quality benchmarks and studies evaluating optical biopsy have not shown diagnostic test performance results that meet standards set by society guidelines in order to promote its widespread clinical adoption. Optical polyp diagnosis and the current resect and discard approach are too complex for clinical adoption. Thus, clinical implementation of this valuable concept has not been achieved to date and its cost-saving potential has not been realized. In order to effectively operationalize a resect and discard strategy, one must find a different way to distinguish neoplastic from non-neoplastic polyps. There exist differences in the proportion of polyps found to be adenomatous in the left and right colon. One recent study reported that 30% of left-sided polyps and 76% of right-sided polyps were found to be adenomas on histology. Since polyps located in the proximal colon are more likely to be adenomas and polyps in the recto-sigmoid colon are more likely hyperplastic we hypothesized that a model based on polyp location might be able to replace optical biopsy and histopathology. Such an approach would be very simple to adopt by every clinician and would allow for easy adoption into clinical practice.
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?: