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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06340620
Other study ID # 24.017.01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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