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NCT06340620NARecruiting

EUS Examination Using EndoSound Vision System vs. Standard Echoendoscope

Orlando Health, Inc.

Start Date

3/25/2024

Completion Date

12/1/2027

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.

Eligibility Criteria

Age Range: 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.

Interventions

DEVICE

Endoscopic ultrasound examination

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Conditions

Pancreatic DiseasePancreatic CancerPancreatic CystGastrointestinal TumorBile Duct DiseasesBile Duct CancerLymph Node DiseaseSubmucosal Tumor of Gastrointestinal TractGastrointestinal Cancer

Locations

Orlando Health

Orlando, Florida 32806

United States