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This is a randomized trial to compare the standard echoendoscope with the newly developed EndoSound Visual System in the evaluation of lesions in the gastrointestinal tract.
Endoscopic ultrasound (EUS) is the gold standard for evaluation and biopsy of lesions in the pancreaticobiliary tract, subepithelial lesions in the gastrointestinal tract and luminal cancer staging due to its high sensitivity and specificity. Endoscopic ultrasound examination is performed by echoendoscopes, which are endoscopes with an ultrasound probe at the distal end to allow endoscopic ultrasound evaluation. A new endoscopic ultrasound system - the EndoSound Visual System has now been developed for endoscopic ultrasound examination. The EndoSound Visual System is a device that can be attached externally to upper gastrointestinal endoscopes, thereby converting a standard endoscope into an echoendoscope which can then be used to perform an EUS examination.
The aim of this randomized trial is to compare the standard echoendoscope with the newly developed EndoSound Visual System in the evaluation of lesions in the gastrointestinal tract.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard echoendoscope | Active Comparator | Standard echoendoscope will be used and EUS examination will be performed per standard of care. |
|
| EndoSound Vision System | Active Comparator | EndoSound Vision System will be used and EUS examination will be performed per standard of care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic ultrasound examination | Device | Endoscopic ultrasound examination will be performed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of successful completion of the requisite EUS examination | Rate of successful completion of the requisite examination during EUS between the EndoSound Vision System and standard echoendoscopes will be assessed, compared as a percentage of successfully completed examinations between the standard echoendoscope and Endosound Vision System. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Ease of maneuverability of the device | The ease of maneuverability during EUS between the EndoSound Vision System and standard echoendoscopes will be assessed, based on a rating scale of 1 to 5 (whereby 1 is the most easy to maneuver and 5 is the most difficult to maneuver). | 1 day |
| Quality of EUS imaging |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ji Young Bang, MD MPH | Contact | 321-841-2431 | jiyoung.bang@orlandohealth.com | |
| Barbara Broome | Contact | 321-841-4356 | barbara.broome@orlandohealth.com |
| Name | Affiliation | Role |
|---|---|---|
| Ji Young Bang, MD MPH | Orlando Health, Digestive Health Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orlando Health | Recruiting | Orlando | Florida | 32806 | United States |
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The quality of EUS imaging during EUS between the EndoSound Vision System and standard echoendoscopes will be assessed, based on a rating scale of 1 to 5 (whereby 1 is the best quality imaging and 5 is the worst quality imaging). |
| 1 day |
| Ease of performing tissue acquisition | The ease of performing tissue acquisition during EUS between the EndoSound Vision System and standard echoendoscopes will be assessed, based on a rating scale of 1 to 5 (whereby 1 is the most easy to perform and 5 is the most difficult to perform). | 1 day |
| Diagnostic adequacy of procured specimen on onsite evaluation | Rate of diagnostic adequacy of procured tissue specimen on onsite evaluation between the EndoSound Vision System and standard echoendoscopes. | 7 days |
| Diagnostic adequacy of procured specimen in cell block | Rate of diagnostic adequacy of procured tissue specimen in cell block between the EndoSound Vision System and standard echoendoscopes. | 7 days |
| Diagnostic accuracy of procured specimen | Rate of diagnostic accuracy of procured tissue specimen between the EndoSound Vision System and standard echoendoscopes. | 7 days |
| Procedure duration | Duration of procedure between the EndoSound Vision System and standard echoendoscopes. | 1 day |
| Rate of procedure-related adverse events | Rate of procedure-related adverse events between the EndoSound Vision System and standard echoendoscopes. | 7 days |
| Procedure costs | Costs associated with the endoscopic ultrasound procedures between the EndoSound Vision System and standard echoendoscopes. | 7 days |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D010190 | Pancreatic Neoplasms |
| D010181 | Pancreatic Cyst |
| D004067 | Digestive System Neoplasms |
| D001649 | Bile Duct Diseases |
| D001650 | Bile Duct Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004700 | Endocrine System Diseases |
| D003560 | Cysts |
| D001660 | Biliary Tract Diseases |
| D001661 | Biliary Tract Neoplasms |
| D005767 | Gastrointestinal Diseases |
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