Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01CA210544 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of North Carolina, Chapel Hill | OTHER |
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OCT of esophagus | Experimental | optical coherence tomography of esophagus |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| optical coherence tomography | Device | OCT measurements of 5 locations in the esophagus |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Imaged Sites Correctly Categorized as Squamous Mucosa | Percentage of imaged sites correctly categorized by OCT as squamous mucosa when compared to endoscopy. | 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. | at baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at baseline |
Not provided
Inclusion Criteria:
Presenting to University of North Carolina (UNC) for routine care upper endoscopy
Meet one of the following criteria:
Aged 18 to 80
Able to read, comprehend, and understand the informed consent document.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Adam Wax, Ph.D. | Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | OCT of Esophagus | All participants who were able to swallow the OCT probe had optical coherence tomography (OCT) imaging of the esophagus, with measurements in at least 5 locations. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | OCT of Esophagus | All participants who were able to swallow the OCT probe had optical coherence tomography (OCT) imaging of the esophagus, with measurements in at least 5 locations. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Imaged Sites Correctly Categorized as Squamous Mucosa | Percentage of imaged sites correctly categorized by OCT as squamous mucosa when compared to endoscopy. | Participants who completed the study. | Posted | Number | percentage of imaged sites | at baseline |
|
|
1 week
Subjects were contacted 1 week after OCT imaging to assess any adverse events.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | OCT of Esophagus | All participants who were able to swallow the OCT probe had optical coherence tomography (OCT) imaging of the esophagus, with measurements in at least 5 locations. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| sore throat | Surgical and medical procedures | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Adam Wax | Duke University | 919-660-5143 | a.wax@duke.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jan 9, 2018 | Oct 1, 2020 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 14, 2020 | Feb 10, 2021 | Prot_SAP_001.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001471 | Barrett Esophagus |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D041623 | Tomography, Optical Coherence |
| ID | Term |
|---|---|
| D041622 | Tomography, Optical |
| D061848 | Optical Imaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Stage of Barrett's Esophagus | Count of Participants | Participants |
|
|
| Primary | 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. | Participants who completed the study. | Posted | Number | percentage of imaged sites | at baseline |
|
|
|
| Secondary | 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. | Participants who completed the study. | Posted | Number | percentage of imaged sites | at baseline |
|
|
|
| 0 |
| 53 |
| 0 |
| 53 |
| 8 |
| 53 |
| bloating | Surgical and medical procedures | Systematic Assessment |
|
| nausea / vomiting | Surgical and medical procedures | Systematic Assessment |
|
| epigastric pain | Surgical and medical procedures | Systematic Assessment |
|
| esophageal pain | Surgical and medical procedures | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D004066 |
| Digestive System Diseases |
| D003933 | Diagnosis |
| D014054 | Tomography |
| D008919 | Investigative Techniques |