EUS Examination Using EndoSound Vision System vs. Standard Echoendoscope

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06340620
• Other study ID #: 24.017.01
• Status: Recruiting
• Phase: N/A
• Start date: March 25, 2024
• Est. completion date: December 2027

Study information

• Verified date: March 2024
• Source: Orlando Health, Inc.
• Contact: Ji Young Bang, MD MPH
• Phone: 321-841-2431
• Email: jiyoung.bang[@]orlandohealth.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: December 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bile Duct Cancer
• Bile Duct Diseases
• Bile Duct Neoplasms
• Cholangiocarcinoma
• Digestive System Neoplasms
• Gastrointestinal Cancer
• Gastrointestinal Neoplasms
• Gastrointestinal Tumor
• Lymph Node Disease
• Pancreatic Cancer
• Pancreatic Cyst
• Pancreatic Disease
• Pancreatic Diseases
• Submucosal Tumor of Gastrointestinal Tract

Intervention

Device:
• Endoscopic ultrasound examination
Endoscopic ultrasound examination will be performed.

Locations

Country	Name	City	State
United States	Orlando Health	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Orlando Health, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	1 day
Secondary	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).	1 day
Secondary	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).	1 day
Secondary	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).	1 day
Secondary	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.	7 days
Secondary	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.	7 days
Secondary	Diagnostic accuracy of procured specimen	Rate of diagnostic accuracy of procured tissue specimen between the EndoSound Vision System and standard echoendoscopes.	7 days
Secondary	Procedure duration	Duration of procedure between the EndoSound Vision System and standard echoendoscopes.	1 day
Secondary	Rate of procedure-related adverse events	Rate of procedure-related adverse events between the EndoSound Vision System and standard echoendoscopes.	7 days
Secondary	Procedure costs	Costs associated with the endoscopic ultrasound procedures between the EndoSound Vision System and standard echoendoscopes.	7 days