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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01CA103769-07 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Cancer Institute (NCI) | NIH |
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The main purpose of this research is to test the feasibility and tolerability of the tethered capsule Optical Frequency Domain Imaging (OFDI)
A total of 56 subjects with Barrett's Esophagus, EoE and healthy volunteers will be asked to swallow the OFDI capsule while being unsedated. The capsule is attached to a tether that allows the capsule operator to navigate the capsule as it progresses down the esophagus using natural propulsion called peristalsis as well as to bring it back up to pulled out of the mouth when the procedure is done.
As the capsule progresses down the esophagus, multiple, two dimensional, microscopic cross- sectional images of the esophagus are acquired.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OFDI Capsule Imaging | Experimental | Subject will swallow the OFDI capsule and imaging will be acquired using the OFDI Imaging system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OFDI Capsule | Device | Imaging of the esophagus using the OFDI Capsule and system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of OFDI Imaging in Subjects Swallowing the OFDI Capsule | Number of subjects from whom the quality OFDI imaging was obtained | Images will be acquired during the OFDI imaging session which should take an average of 5 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guillermo Tearney, MD., PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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In this feasibility study we try to establish the overall number of participants who are able to swallow the capsule and provide us with quality imaging using this new technology. At this point we do no distinguish tolerability separately in each of the three groups and are treating them as one.
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| ID | Title | Description |
|---|---|---|
| FG000 | OFDI Capsule Imaging | Subject will swallow the OFDI capsule and imaging will be acquired using the OFDI Imaging system. OFDI Capsule: Imaging of the esophagus using the OFDI Capsule and system |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | OFDI Capsule Imaging | Subject will swallow the OFDI capsule and imaging will be acquired using the OFDI Imaging system. OFDI Capsule: Imaging of the esophagus using the OFDI Capsule and system |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Feasibility of OFDI Imaging in Subjects Swallowing the OFDI Capsule | Number of subjects from whom the quality OFDI imaging was obtained | Posted | Count of Participants | Participants | Images will be acquired during the OFDI imaging session which should take an average of 5 minutes |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | OFDI Capsule Imaging | Subject will swallow the OFDI capsule and imaging will be acquired using the OFDI Imaging system. OFDI Capsule: Imaging of the esophagus using the OFDI Capsule and system |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gary Tearney | Mass General Hospital | 617-724-2979 | gtearney@partners.org |
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| ID | Term |
|---|---|
| D001471 | Barrett Esophagus |
| D057765 | Eosinophilic Esophagitis |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 0 |
| 56 |
| 0 |
| 56 |
| 0 |
| 56 |
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| D004066 |
| Digestive System Diseases |
| D004941 | Esophagitis |
| D005759 | Gastroenteritis |
| D004802 | Eosinophilia |
| D007960 | Leukocyte Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |