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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-26

Study Completion Date

2020-01-27

Brief Summary

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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.

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Detailed Description

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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

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Patient

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Diagnostic

Patients undergo standard of care white light endoscopy (WLE) and hyperspectral endoscopy (HySE) during routine colonoscopy procedure.

Group Type EXPERIMENTAL

Hyperspectral Endoscopy (HySE)

Intervention Type PROCEDURE

Undergo hyperspectral endoscopy

White Light Endoscopy (WLE)

Intervention Type DEVICE

Undergo white light endoscopy

Interventions

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Hyperspectral Endoscopy (HySE)

Undergo hyperspectral endoscopy

Intervention Type PROCEDURE

White Light Endoscopy (WLE)

Undergo white light endoscopy

Intervention Type DEVICE

Other Intervention Names

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Hyperspectral Endoscopic Imaging (HSI) White Light Endoscopic Imaging

Eligibility Criteria

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Inclusion Criteria

* Ability to understand and the willingness to sign a written informed consent document
* Patients scheduled for a standard of care screening or surveillance colonoscopy