Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2026-01-04 @ 4:41 AM
Study NCT ID:
NCT04172493
Status:
COMPLETED
Last Update Posted:
2020-05-08
First Post:
2019-11-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hyperspectral Endoscopy Imaging for the Early Detection of Precancerous Lesions in Average Risk Patients
Sponsor:
OHSU Knight Cancer Institute
Organization:
Study Overview
Official Title:
Hyperspectral Endoscopy Imaging for Early Detection of Precancerous Lesions in Average Risk Patients: Proof of Principle
Status:
COMPLETED
Status Verified Date:
2020-05
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:
This trial studies whether hyperspectral endoscopy improves visualization of abnormal tissue in average risk patients during standard-of-care colonoscopies. Hyperspectral endoscopy is an emerging technique that has the potential to enable the signals from blood to be resolved from tissue-specific signals. Image-enhanced endoscopy may improve visualization of abnormal colonic tissue when compared to the standard-of-care high-definition white light endoscopy.
Detailed Description:
PRIMARY OBJECTIVE:
I. To assess whether use of hyperspectral endoscopy (HySE) can improve visualization of abnormal colonic tissue.
SECONDARY OBJECTIVES:
I. To assess whether use of HySE could reduce the rate of missed flat polyps.
II. To assess whether use of HySE might in the future reduce the incomplete resection rate (IRR).
III. To examine accuracy of practitioners in predicting polyp histology.
OUTLINE:
Patients undergo standard of care white light endoscopy and hyperspectral endoscopy during routine colonoscopy procedure.
After completion of study, patients who experience a colonoscopy-related severe adverse event are followed up until resolution or stabilization of the event.
I. To assess whether use of hyperspectral endoscopy (HySE) can improve visualization of abnormal colonic tissue.
SECONDARY OBJECTIVES:
I. To assess whether use of HySE could reduce the rate of missed flat polyps.
II. To assess whether use of HySE might in the future reduce the incomplete resection rate (IRR).
III. To examine accuracy of practitioners in predicting polyp histology.
OUTLINE:
Patients undergo standard of care white light endoscopy and hyperspectral endoscopy during routine colonoscopy procedure.
After completion of study, patients who experience a colonoscopy-related severe adverse event are followed up until resolution or stabilization of the event.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2019-06087 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| ONC-19132-L | None | None | View | |
| STUDY00018947 | OTHER | OHSU Knight Cancer Institute | View | |
| P30CA069533 | NIH | None | https://reporter.nih.gov/quic… | View |