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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01DK091923-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The goal of this study is to test the feasibility and the tolerability of a tethered spectrally encoded confocal microscopy (SECM) capsule and to use it to image the esophagus.
96 participants including healthy volunteers, patients with a suspicion of having Eosinophilic Esophagitis (EoE) and patients with a current or prior clinical diagnosis of EoE will be recruited and asked to swallow the SECM capsule while being awake and unsedated. The capsule is attached to a tether which allows the operator to control as well as navigate the capsule as it progresses down the esophagus using natural propulsive force called peristalsis.
As the capsule progresses, multiple 2-dimensional cross-sectional images of the esophagus are acquired. Images are analyzed at a later stage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Imaging | Experimental | Participant will swallow the SECM capsule and Imaging will be performed using the SECM Imaging system. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SECM Capsule | Device | Imaging of the esophagus using the SECM capsule and system |
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| Measure | Description | Time Frame |
|---|---|---|
| SECM Imaging quality. Assessed qualitative values like resolution, tissue architecture, background scatter etc. | An investigator will qualitatively assess the the Feasibility of SECM Capsule and Imaging in EoE participant versus Healthy Controls. He will assess the quality of the recorded images and movies obtained with each exam after the imaging is completed. The images obtained by the SECM Capsule will be compared to the images obtained by clinical endoscopy if available. | A single 20 minute visit (5-7 minute imaging). |
| Tolerability of SECM Capsule Imaging Procedure in Healthy and EoE Participant, measured by feedback scores. | After participating in the study, the participants will be asked for feedback about tolerability of the procedure using a questionnaire. This entails questions about discomfort levels and the participants ability to tolerate the tether and capsule during the whole and parts of the procedures. using a 0 -10 scale, participants will score how comfortable the procedure was during each stage. 10 being the most discomfort and 0 being the least discomfort. | Questionnaire adminstered directly after the imaging portion has been completed. |
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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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| ID | Term |
|---|---|
| D057765 | Eosinophilic Esophagitis |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D004941 | Esophagitis |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| D005759 |
| Gastroenteritis |
| D004802 | Eosinophilia |
| D007960 | Leukocyte Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D007154 | Immune System Diseases |