Bile Duct Cancer, Bile Duct Diseases, Gastrointestinal Cancer, Gastrointestinal Tumor, Lymph Node Disease, Pancreatic Cancer, Pancreatic Cyst, Pancreatic Disease, Submucosal Tumor of Gastrointestinal Tract
Conditions
Keywords
Endoscopic ultrasound, EndoSound Vision System, Randomized trial
Brief summary
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.
Detailed description
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.
Interventions
DEVICEEndoscopic ultrasound examination
Endoscopic ultrasound examination will be performed.
Sponsors
Orlando Health, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Any patient undergoing EUS examination for evaluation of the pancreas, bile duct, mediastinal or intraabdominal lymph nodes, or luminal lesions in the esophagus, stomach, duodenum or colon.
Exclusion criteria
* Age \< 18 years. * Unable to obtain consent for the procedure from either the patient or LAR. * Intrauterine pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of successful completion of the requisite EUS examination | 1 day | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedure costs | 7 days | Costs associated with the endoscopic ultrasound procedures between the EndoSound Vision System and standard echoendoscopes. |
| Ease of maneuverability of the device | 1 day | 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). |
| Quality of EUS imaging | 1 day | 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). |
| Ease of performing tissue acquisition | 1 day | 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). |
| Rate of procedure-related adverse events | 7 days | Rate of procedure-related adverse events between the EndoSound Vision System and standard echoendoscopes. |
| Diagnostic adequacy of procured specimen in cell block | 7 days | Rate of diagnostic adequacy of procured tissue specimen in cell block between the EndoSound Vision System and standard echoendoscopes. |
| Diagnostic accuracy of procured specimen | 7 days | Rate of diagnostic accuracy of procured tissue specimen between the EndoSound Vision System and standard echoendoscopes. |
| Procedure duration | 1 day | Duration of procedure between the EndoSound Vision System and standard echoendoscopes. |
| Diagnostic adequacy of procured specimen on onsite evaluation | 7 days | Rate of diagnostic adequacy of procured tissue specimen on onsite evaluation between the EndoSound Vision System and standard echoendoscopes. |
Countries
United States
Contacts
Primary ContactJi Young Bang, MD MPH
Backup ContactBarbara Broome
Outcome results
None listed