EUS Examination Using EndoSound Vision System vs. Standard Echoendoscope

Orlando Health, Inc.

Status: Enrolling

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

Treatments: Device: Endoscopic ultrasound examination

Study type: Interventional

Funder types: Other

Identifiers

NCT06340620

24.017.01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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140 participants in 2 patient groups

Standard echoendoscope

Active Comparator group

Description:

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

Treatment:

Device: Endoscopic ultrasound examination

EndoSound Vision System

Active Comparator group

Description:

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

Treatment:

Device: Endoscopic ultrasound examination