EUS Examination Using EndoSound Vision System vs. Standard Echoendoscope

NCT06340620 — Not applicable, Recruiting, 140 participants, Orlando Health, Inc.

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Randomized Trial of Endoscopic Ultrasound Examination Using EndoSound Vision System vs. Standard Echoendoscope

Registry	NCT06340620
Status	Recruiting
Phase	Not applicable
Study type	Interventional; randomized, crossover, masking: triple, diagnostic
Enrollment	140 (Estimated)
Sponsor	Orlando Health, Inc. (Other)
Conditions	Pancreatic Disease, Pancreatic Cancer, Pancreatic Cyst, Gastrointestinal Tumor, Bile Duct Diseases, Bile Duct Cancer, Lymph Node Disease, Submucosal Tumor of Gastrointestinal Tract, Gastrointestinal Cancer
Interventions	Endoscopic ultrasound examination (Device)
Dates	start 2026-10-01 (estimated), primary completion 2027-12-01 (estimated), completion 2028-12-01 (estimated), first posted 2024-04-01, last updated 2026-10-20
Locations	1 site in United States

-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.

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+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 and interventions

Arm	Type	Interventions	Description
Standard echoendoscope	Active comparator	Device: Endoscopic ultrasound examination	Standard echoendoscope will be used and EUS examination will be performed per standard of care.
EndoSound Vision System	Active comparator	Device: Endoscopic ultrasound examination	EndoSound Vision System will be used and EUS examination will be performed per standard of care.

Endoscopic ultrasound examination (Device): Endoscopic ultrasound examination will be performed.

+Outcome measures

Primary outcomes

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 outcomes

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).
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.
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.
Rate of procedure-related adverse events [7 days]: Rate of procedure-related adverse events between the EndoSound Vision System and standard echoendoscopes.
Procedure costs [7 days]: Costs associated with the endoscopic ultrasound procedures between the EndoSound Vision System and standard echoendoscopes.

+Eligibility

Sex: All, ages: 18 Years to 100 Years

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.

+Locations (1)

Facility	City	Country	Status
Orlando Health	Orlando, Florida	United States	Recruiting

+Investigators

Ji Young Bang, MD MPH, Principal investigator, Orlando Health, Digestive Health Institute