Randomized Trial of Endoscopic Ultrasound Examination Using EndoSound Vision System vs. Standard Echoendoscope
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.
Arms & interventions
- DeviceEndoscopic ultrasound examination
Endoscopic ultrasound examination will be performed.
Outcome measures
Primary
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.
Time frame: 1 day
Secondary
Ease of maneuverability of the device
Time frame: 1 day
Quality of EUS imaging
Time frame: 1 day
Ease of performing tissue acquisition
Time frame: 1 day
Diagnostic adequacy of procured specimen on onsite evaluation
Time frame: 7 days
Diagnostic adequacy of procured specimen in cell block
Time frame: 7 days
Diagnostic accuracy of procured specimen
Time frame: 7 days
Procedure duration
Time frame: 1 day
Rate of procedure-related adverse events
Time frame: 7 days
Procedure costs
Time frame: 7 days
Eligibility criteria
Study locations (1)
Orlando Health
Orlando, Florida, 32806