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The purpose of this study is to test feasibility of a redesigned tethered capsule catheter that contains an integrated micro-motor. Investigators will be testing imaging of this new technology in healthy volunteers.
10 healthy volunteers will be enrolled and asked to swallow the Distal Scanning Capsule. The subjects will be awake and un-sedated.
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 |
|---|---|---|---|
| OFDI capsule imaging | 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 esophagus using OFDI capsule and system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants For Whom Good Quality Images Were Recorded After Swallowing The OFDI Capsule | An investigator to assess the quality of the recorded images obtained with each exam after imaging has been completed | Approximate 20 minute visit (5 min image acquisition) |
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Inclusion Criteria:
Exclusion Criteria:
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Healthy Volunteers
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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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No significant events occurred after participants enrollment.
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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 esophagus using 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 |
| 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 | Number of Participants For Whom Good Quality Images Were Recorded After Swallowing The OFDI Capsule | An investigator to assess the quality of the recorded images obtained with each exam after imaging has been completed | Posted | Count of Participants | Participants | Approximate 20 minute visit (5 min image acquisition) |
|
|
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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 esophagus using OFDI capsule and system |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gary Tearney, MD | Massachusetts General Hospital | 617-724-2979 | gtearney@partners.org |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
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| 0 |
| 4 |
| 0 |
| 4 |
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