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The goal of this study is to test the feasibility and acceptability of tethered capsule Optical Coherence Tomography (OCT) endomicroscopy as a device for population-based screening in the primary care practice environment.
60 healthy volunteers scheduled for a routine primary care visit will be recruited and asked to swallow the OCT 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 through the esophagus, multiple images of the esophagus are acquired and later analyzed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MGH OCT Imaging Capsule | Experimental | Subject will swallow the OCT capsule and images will be acquired using the OCT Imaging system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MGH OCT Imaging Capsule | Device | Imaging of the esophagus using the OCT Capsule and system. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Esophageal Imaging in Subjects Who Successfully Swallow the OCT Capsule in the Primary Care Setting. | Number of Participants able to swallow the capsule successfully. An investigator will assess the quality of the recorded images and movies obtained with each exam after imaging has been completed. This is a feasibility study and was not used for any diagnosis. | Approximate 20min visit (5min image acquisition) |
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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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A total number of 60 Participants were enrolled in the study
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| ID | Title | Description |
|---|---|---|
| FG000 | Feasibility of Tethered Capsule Endomicroscopy | Number of participants able to swallow the capsule and capture OCT images successfully in the PCP setting. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Feasibility | Number of participants able to swallow the capsule and capture OCT images successfully. |
| Units | Counts |
|---|---|
| Participants |
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| 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 Esophageal Imaging in Subjects Who Successfully Swallow the OCT Capsule in the Primary Care Setting. | Number of Participants able to swallow the capsule successfully. An investigator will assess the quality of the recorded images and movies obtained with each exam after imaging has been completed. This is a feasibility study and was not used for any diagnosis. | Posted | Count of Participants | Participants | Approximate 20min visit (5min image acquisition) |
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During the procedure and 10 minutes after
The adverse events were collected systematically for this study. The definition of adverse events is the same as clinicaltrials.gov definition.
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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 OCT Imaging Capsule | Subject will swallow the OCT capsule and images will be acquired using the OCT Imaging system. MGH OCT Imaging Capsule: Imaging of the esophagus using the OCT Capsule and system. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anna Gao RN. | Massachusetts General Hospital | 617-643-6092 | tearneylabtrials@partners.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 4, 2017 | Dec 9, 2019 | Prot_SAP_000.pdf |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Participants |
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| 0 |
| 60 |
| 0 |
| 60 |
| 0 |
| 60 |
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