NCT04172493

Hyperspectral Endoscopy Imaging for the Early Detection of Precancerous Lesions in Average Risk Patients

Hyperspectral Endoscopy Imaging for Early Detection of Precancerous Lesions in Average Risk Patients: Proof of Principle

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: OHSU Knight Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Patient

Interventions

Type	Name	Description
PROCEDURE	Hyperspectral Endoscopy (HySE)	Undergo hyperspectral endoscopy
DEVICE	White Light Endoscopy (WLE)	Undergo white light endoscopy

Timeline

• Start date: 2019-08-26
• Primary completion: 2020-01-27
• Completion: 2020-01-27
• First posted: 2019-11-21
• Last updated: 2020-05-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study