EUS Examination Using EndoSound Vision System vs. Standard Echoendoscope

Not Applicable

Recruiting

• Conditions: Pancreatic Cyst; Pancreatic Cancer; Bile Duct Cancer; Gastrointestinal Tumor; Bile Duct Diseases; Gastrointestinal Cancer; Pancreatic Disease; Lymph Node Disease; Submucosal Tumor of Gastrointestinal Tract
• Interventions: Device: Endoscopic ultrasound examination

• Registration Number: NCT06340620
• Lead Sponsor: Orlando Health, Inc.

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.

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-15
• Study Start: 2024-03-25
• Study First Submitted QC: 2024-03-25
• Last Update Submitted: 2024-03-25
• Study First Posted: 2024-04-01
• Last Update Posted: 2024-04-01
• Primary Completion: 2026-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Standard echoendoscope	Endoscopic ultrasound examination	Standard echoendoscope will be used and EUS examination will be performed per standard of care.
EndoSound Vision System	Endoscopic ultrasound examination	EndoSound Vision System will be used and EUS examination will be performed per standard of care.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
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.
Rate of procedure-related adverse events	7 days	Rate of procedure-related adverse events 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).
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.
Procedure duration	1 day	Duration of procedure 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.

Trial Locations

Locations (1)

Orlando Health; 🇺🇸 Orlando, Florida, United States