Patient
Conditions
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.
Interventions
PROCEDUREHyperspectral Endoscopy (HySE)
Undergo hyperspectral endoscopy
Undergo white light endoscopy
Sponsors
National Cancer Institute (NCI)
Oregon Health and Science University
OHSU Knight Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Exclusion criteria
* Any condition that, in the opinion of the investigator, precludes the patient from completion of the study procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Spectral profiles corresponding to normal versus abnormal colonic tissue | 1 year | Will apply a multivariate statistical analysis such as spectral angle mapper to determine whether the spectra are significantly different as determined by light spectral bandwidth measurements. |
| Image quality | 1 year | Assessed by the endoscopist, based on level of confidence in delineating the area of interest. Will assess and compare the number of polyps found by standard light endoscopy and narrow band imaging with hyperspectral endoscopy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Imaging differences in polyp characteristics documented upon post-procedure video review | 1 year | Will be compared with the final read of the pathology of the polyps. A Pearson X2 test or equivalent test will be applied. When applicable, Fisher exact test and Pearson X2 test will be used to test for differences in categorical variables, which include analysis of polyp morphologic structure and location. A student t test or equivalent statistical test will be used to test for differences in continuous variables, including polyp diameter. |
Countries
United States
Outcome results
None listed