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The study is being done to test the feasibility and tolerability of a SECM imaging probe in patients with Barrett's Esophagus (BE).
Subjects will undergo SECM probe imaging while they are under conscious sedation. Spiral SECM imaging will be performed continuously over a pre-determined length. Patients will later be asked for their feedback.
Subjects with a previous diagnosis of Barrett's Esophagus will be recruited in the study and undergo SECM probe imaging while using conscious sedation, pulse oximetry and blood pressure monitoring. The probe will be inserted the predetermined required distance in the esophagus using a guide wire.
Once the SECM imaging probe is in place, spiral SECM image data will be continuously collected over a pre-determined length (approximately 5cm).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SECM Probe Imaging | Experimental | SECM probe will be guided to a pre-determined length in the esophagus and spiral imaging will be performed using the SECM Imaging System. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SECM Probe | Device | Imaging of the esophagus using SECM probe and system. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Tolerability of the Procedure | We were monitoring the number of participants able to tolerate the procedure. All six participating subjects have been asked for a feedback about tolerability of the procedure using a specific tolerability questionnaire. | During the procedure |
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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 | Title | Description |
|---|---|---|
| FG000 | SECM Probe Imaging | SECM probe will be guided to a pre-determined length in the esophagus and spiral imaging will be performed using the SECM Imaging System. SECM Probe: Imaging of the esophagus using SECM probe and system. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SECM Probe Imaging | SECM probe will be guided to a pre-determined length in the esophagus and spiral imaging will be performed using the SECM Imaging System. SECM Probe: Imaging of the esophagus using SECM probe and 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 With Tolerability of the Procedure | We were monitoring the number of participants able to tolerate the procedure. All six participating subjects have been asked for a feedback about tolerability of the procedure using a specific tolerability questionnaire. | All six study participants completed the study and the obtained data has been analyzed | Posted | Count of Participants | Participants | During the procedure |
|
During the procedure
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 | SECM Probe Imaging | SECM probe will be guided to a pre-determined length in the esophagus and spiral imaging will be performed using the SECM Imaging System. SECM Probe: Imaging of the esophagus using SECM probe and system. No adverse events has been reported. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Guillermo Tearney, PI | Massachusetts General Hospital | 617-724-2979 | gtearney@partners.org |
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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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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| 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 | Number | participants |
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| Units | Counts |
|---|
| Participants |
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| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
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| D004066 |
| Digestive System Diseases |