An interventional study of Endoscopic ultrasound examination in Pancreatic Disease, Pancreatic Cancer and Pancreatic Cyst, sponsored by Orlando Health, Inc.. Recruiting at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-04-01.
Sponsored by Orlando Health, Inc. · Not applicable, Interventional, and Diagnostic
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.
779 studies on the registry are indexed under Gastrointestinal Neoplasms; 231 are open to participants now.
This study's planned enrollment of 140 is above the median of 60 across 569 interventional studies indexed under Gastrointestinal Neoplasms.
Browse Gastrointestinal Neoplasms studies →Orlando Health, Inc. is the lead sponsor of 28 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Standard echoendoscope will be used and EUS examination will be performed per standard of care.
Device: Endoscopic ultrasound examination
EndoSound Vision System will be used and EUS examination will be performed per standard of care.
Device: Endoscopic ultrasound examination
Endoscopic ultrasound examination will be performed.
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
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).
Time frame: 1 day
Quality of EUS imaging
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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 7 days
Diagnostic accuracy of procured specimen
Rate of diagnostic accuracy of procured tissue specimen between the EndoSound Vision System and standard echoendoscopes.
Time frame: 7 days
Procedure duration
Duration of procedure between the EndoSound Vision System and standard echoendoscopes.
Time frame: 1 day
Rate of procedure-related adverse events
Rate of procedure-related adverse events between the EndoSound Vision System and standard echoendoscopes.
Time frame: 7 days
Procedure costs
Costs associated with the endoscopic ultrasound procedures between the EndoSound Vision System and standard echoendoscopes.
Time frame: 7 days
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Orlando Health, Inc.