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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01CA184102-01 | 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 the imaging quality of the modified, larger diameter, tethered Spectrally Encoded Confocal Microscopy (SECM) capsule in healthy subjects, subjects with Barrett's Esophagus (BE), and subjects with Gastroesophageal reflux disease (GERD).
36 subjects including 12 healthy volunteers, 12 patients with Barrett's Esophagus and 12 with Gastroesophageal reflux disease will be enrolled and asked to swallow the SECM HITEC Capsule. The subjects will be awake and unsedated.
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 natural propulsive force called peristalsis.
As the capsule progresses through the esophagus, multiple images of the esophagus are acquired in real time to be analyzed later.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MGH SECM Imaging Capsule | Experimental | Subject will swallow the SECM imaging capsule and images will be acquired using the SECM Imaging system. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MGH SECM Imaging Capsule | Device | Imaging of the Esophagus using the SECM capsule and SECM Imaging system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility for Imaging of Esophagus Using an SECM Tethered Endoscopic Capsule. | The number of subjects from whom successful SECM imaging was obtained | 20 minute visit (5-7 minute imaging) |
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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 study we were trying to establish how many participants can provide us with quality imaging using this new technology. Therefore we treated them as one group. 2 healthy subjects and one with BE were enrolled.
Upon reviewing imaging data it was concluded that this new technology is not optimal for the study and the enrollment was stopped.
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| ID | Title | Description |
|---|---|---|
| FG000 | MGH SECM Imaging Capsule | Subject will swallow the SECM imaging capsule and images will be acquired using the SECM Imaging system. MGH SECM Imaging Capsule: Imaging of the Esophagus using the SECM capsule and SECM Imaging system |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MGH SECM Imaging Capsule | Subject will swallow the new large SECM imaging capsule and images will be acquired using the SECM Imaging 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 for Imaging of Esophagus Using an SECM Tethered Endoscopic Capsule. | The number of subjects from whom successful SECM imaging was obtained | Posted | Count of Participants | Participants | 20 minute visit (5-7 minute imaging) |
|
|
During the procedure and 10 minutes after
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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 | MGH SECM Imaging Capsule | Subject will swallow the SECM imaging capsule and images will be acquired using the SECM Imaging system. The imaging quality will be reviewed. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gary Tearney, MD | Mass General Hospital | 617-724-2979 | gtearney@partners.org |
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| ID | Term |
|---|---|
| D001471 | Barrett Esophagus |
| D005764 | Gastroesophageal Reflux |
| 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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| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
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| D004066 |
| Digestive System Diseases |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |