An interventional study of optical coherence tomography in Barrett Esophagus, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-04-06.
Sponsored by Duke University · Not applicable, Interventional, and Diagnostic
This is a pilot study to test a newly developed optical coherence tomography (OCT) device to determine 1) whether adequate tissue contact can be attained to acquire high quality images, and 2) to identify if these images can discern whether the imaged tissue is squamous or Barrett's Esophagus (BE) epithelium.
Meet one of the following criteria:
Exclusion Criteria:
optical coherence tomography of esophagus
Device: optical coherence tomography
OCT measurements of 5 locations in the esophagus
Percentage of Imaged Sites Correctly Categorized as Squamous Mucosa
Percentage of imaged sites correctly categorized by OCT as squamous mucosa when compared to endoscopy.
Time frame: at baseline
Percentage of Imaged Sites Correctly Categorized as Barrett's Mucosa
Percentage of images site correctly categorized by OCT as Barrett's mucosa when compared to endoscopy.
Time frame: at baseline
Percentage of Imaged Sites With Adequate Tissue Contact to Acquire a High Quality Image
Percentage of imaged sites that achieved adequate tissue contact to acquire high quality OCT images.
Time frame: at baseline
| Milestone | OCT of Esophagus |
|---|---|
| Started | 53 |
| Completed | 37 |
| Not completed | 16 |
| Withdrew: Unable to swallow oct probe | 16 |
Percentage of imaged sites correctly categorized by OCT as squamous mucosa when compared to endoscopy.
| percentage of imaged sites | OCT of Esophagus |
|---|---|
| Percentage of Imaged Sites Correctly Categorized as Squamous Mucosa | 93.1 |
Percentage of images site correctly categorized by OCT as Barrett's mucosa when compared to endoscopy.
| percentage of imaged sites | OCT of Esophagus |
|---|---|
| Percentage of Imaged Sites Correctly Categorized as Barrett's Mucosa | 84.6 |
Percentage of imaged sites that achieved adequate tissue contact to acquire high quality OCT images.
| percentage of imaged sites | OCT of Esophagus |
|---|---|
| Percentage of Imaged Sites With Adequate Tissue Contact to Acquire a High Quality Image | 80.5 |
Collected over 1 week. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| OCT of Esophagus | 0/53 (0%) | 0/53 (0%) | 8/53 (15.1%) |
| Event | OCT of Esophagus |
|---|---|
| sore throatSurgical and medical procedures | 4/53 |
| bloatingSurgical and medical procedures | 1/53 |
| nausea / vomitingSurgical and medical procedures | 1/53 |
| epigastric painSurgical and medical procedures | 1/53 |
| esophageal painSurgical and medical procedures | 1/53 |
| Age, Continuous(years) | OCT of Esophagus |
|---|---|
| Mean | 66.3 ± 11.9 |
| Sex: Female, Male(Participants) | OCT of Esophagus |
|---|---|
| Female | 5 |
| Male | 48 |
| Ethnicity (NIH/OMB)(Participants) | OCT of Esophagus |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 53 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | OCT of Esophagus |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 53 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | OCT of Esophagus |
|---|---|
| United States | 53 |
| Stage of Barrett's Esophagus(Participants) | OCT of Esophagus |
|---|---|
| non-dysplastic Barrett's Esophagus | 8 |
| Barrett's Esophagus with low grade dysplasia | 24 |
| Barrett's Esophagus with high grade dysplasia | 21 |
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Duke University