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| ID | Type | Description | Link |
|---|---|---|---|
| 5R21CA141884 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The specific aim of this study is to determine the accuracy of Optical Coherence Tomography (OCT) imaging for screening and diagnosis of the distal esophagus in patients undergoing a clinical esophagogastroduodenoscopy (EGD) procedure. The accuracy of results obtained using the developed OCT imaging probe will be determined and compared with those obtained through the traditional standard of care endoscopic biopsy .
Three hundred consenting patients undergoing routine esophagogastroduodenoscopy (EGD) procedures will be recruited for examination at the gastroesophageal junction with our developed OCT imaging system. The patients will undergo a clinical EGD procedure including endoscopic biopsy. The first step in the procedure follows the standard care with the performance of the surveillance endoscopy. The study experimental procedure will then begin. This study requires the use of a balloon . The balloon placement method is in accordance with current standard clinical practice and involves the insertion of a guide wire through the auxiliary channel of the endoscope. The endoscope is then removed, leaving the guide wire in place, and the OCT balloon is inserted the required distance (determined during the endoscopy) over the guide wire to the GE junction. The OCT balloon will then be inflated and will remain in this fixed position throughout the entire procedure. Once the OCT imaging probe is in place, OCT image data will be continuously collected over the length of the balloon(approximately 5 cm).
It is expected that the total examination time including insertion and inflation of the OCT balloon, OCT imaging and removal of the OCT balloon will add no more than 10 minutes to the total length of the EGD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Optical Frequency Domain imaging System | Experimental | Optical Frequency Domain Imaging (OFDI) balloon based imaging |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optical Frequency Domain Imaging (OFDI) | Device | Optical Frequency Domain (OFDI) imaging of esophagus |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects in Which the Entire Distal Esophagus Can be Visualized Using the Balloon Based Optical Coherence Tomography Screening | Collected entire distal esophagus OFDI Images analyzed and compared to the images obtained during standard of care surveillance endoscopy. | Images will be acquired during the OFDI imaging session which should take an average of 5 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guillermo Tearney, MD PhD | Massachussetts General Hospital | Principal Investigator |
| Norman Nishioka, MD | Massachussetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachussetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Optical Frequency Domain Imaging System | OFDI imaging Optical Frequency Domain Imaging (OFDI) System: OFDI Imaging of esophagus |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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All enrolled subjects completed the study. Imaging was not performed for one subject because of the system malfunction.
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| ID | Title | Description |
|---|---|---|
| BG000 | Optical Frequency Domain Imaging System | OFDI imaging Optical Frequency Domain Imaging (OFDI) System: OFDI Imaging of esophagus |
| 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 | Number of Subjects in Which the Entire Distal Esophagus Can be Visualized Using the Balloon Based Optical Coherence Tomography Screening | Collected entire distal esophagus OFDI Images analyzed and compared to the images obtained during standard of care surveillance endoscopy. | All subjects completed the study with no adverse events. | Posted | Count of Participants | Participants | Images will be acquired during the OFDI imaging session which should take an average of 5 minutes |
|
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During the imaging session
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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 | Optical Frequency Domain Imaging System | OFDI imaging Optical Frequency Domain Imaging (OFDI) System: OFDI Imaging of esophagus |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| aspiration | Investigations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gary 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 |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | 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 |
| 109 |
| 0 |
| 109 |
| 0 |
| 109 |
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| D004066 |
| Digestive System Diseases |