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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01CA184102-02 | 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 goal of this research is to test a distal scanning capsule and a compact redesigned version of the OFDI imaging system in healthy and BE participants to assess ease of use, safety and feasibility in preparation for its use in a multicenter clinical trial.
Ten healthy participants and ten participants with a previous diagnosis of Barrett's Esophagus (BE) will be enrolled in the study.
The capsule is attached to a string-like tether which allows the operator to control as well as navigate the capsule as it progresses down the esophagus using peristalsis.
Images of the esophagus will be acquired in real time to be analyzed later.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OFDI Imaging | Experimental | Experimental OFDI Imaging |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental OFDI Imaging | Device | Imaging of the esophagus with a compact OFDI system and distal scanning catheter |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of quality and performance of Compact Imaging System (CIS) | Images obtained from the CIS will be assessed for quality and compared to images acquired from the previous imaging system | 5-7 Minutes of imaging |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juleen Guoy, RN | Contact | 617-726-5317 | Tearneylabtrials@partners.org | |
| Anita Chung, RN | Contact | 617-724-4515 | Tearneylabtrials@partners.org |
| Name | Affiliation | Role |
|---|---|---|
| Guillermo Tearney, MD, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
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| ID | Term |
|---|---|
| D001471 | Barrett Esophagus |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| D004066 |
| Digestive System Diseases |