EUS Examination Using EndoSound Vision System vs. Standard Echoendoscope

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-25

Study Completion Date

2027-12-31

Brief Summary

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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

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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.

Conditions

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Pancreatic Disease Pancreatic Cancer Pancreatic Cyst Gastrointestinal Tumor Bile Duct Diseases Bile Duct Cancer Lymph Node Disease Submucosal Tumor of Gastrointestinal Tract Gastrointestinal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Standard echoendoscope

Standard echoendoscope will be used and EUS examination will be performed per standard of care.

Group Type ACTIVE_COMPARATOR

Endoscopic ultrasound examination

Intervention Type DEVICE

Endoscopic ultrasound examination will be performed.

EndoSound Vision System

EndoSound Vision System will be used and EUS examination will be performed per standard of care.

Group Type ACTIVE_COMPARATOR

Endoscopic ultrasound examination

Intervention Type DEVICE

Endoscopic ultrasound examination will be performed.

Interventions

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Endoscopic ultrasound examination

Endoscopic ultrasound examination will be performed.

Intervention Type DEVICE

Eligibility Criteria

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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.