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The goal of this research is to conduct a pilot clinical study to evaluate the potential use of esophageal Optical Frequency Domain Imaging (OFDI) for assessing the success and degree of injury associated with therapeutic radiofrequency ablation techniques.
This is a single center pilot study conducted in 30 patients scheduled for therapeutic intervention. As the purpose of the study is to assess the response of the esophagus to radio frequency (RF) ablation, and the degree of residual Barrett's Esophagus (BE) remaining following treatment, OFDI imaging of study participants will occur prior to the scheduled BARRX RF treatment, and at the standard 3 and 6 month follow-up visits.
Following initial visual surveillance of the esophagus, the study experimental procedure will begin. Imaging will be performed with the OFDI system in 4 longitudinal (~5cm) volumetric segments that are spaced equally circumferentially along the esophagus in a similar fashion to the standard 4-quadrant biopsy protocol.
Each of the 4 OFDI imaging segments will be acquired in less than 1 minute.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MGH OFDI Imaging | Experimental | OFDI imaging |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MGH OFDI Imaging | Device | Imaging of Esophagus with OFDI system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of OFDI Imaging as Determined by Number of Successful Imaging Sessions | Images will be taken and compared to standard of care biopsy to assess the success and degree of injury associated with radiofrequency ablation techniques. A successful imaging session is defined as any session where the OFDI device was able to take and produce discernible and clear data that is comparable to corresponding biopsy histopathology. It is considered unsuccessful if we were unable to produce OFDI data and/or attain a corresponding biopsy. | During the OFDI imaging session (about 5 minutes) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guillermo Tearney, MD PhD | Massachusetts General Hospital | Principal Investigator |
| Norman Nishioka, MD | 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 | MGH OFDI Imaging | OFDI imaging MGH OFDI Imaging: Imaging of Esophagus with OFDI system |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MGH OFDI Imaging | OFDI imaging MGH OFDI Imaging: Imaging of Esophagus with OFDI 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 of OFDI Imaging as Determined by Number of Successful Imaging Sessions | Images will be taken and compared to standard of care biopsy to assess the success and degree of injury associated with radiofrequency ablation techniques. A successful imaging session is defined as any session where the OFDI device was able to take and produce discernible and clear data that is comparable to corresponding biopsy histopathology. It is considered unsuccessful if we were unable to produce OFDI data and/or attain a corresponding biopsy. | A total of 17 Participants took place in this study. | Posted | Number | Imaging sessions | During the OFDI imaging session (about 5 minutes) | Completed Imaging sessions | Completed Imaging sessions |
|
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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 OFDI Imaging | OFDI imaging MGH OFDI Imaging: Imaging of Esophagus with OFDI system |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. 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 |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| Completed Imaging sessions |
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
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| D004066 |
| Digestive System Diseases |