Clinical trial NCT06340620: EUS Examination Using EndoSound Vision System vs. Standard Echoendoscope
Official title: Randomized Trial of Endoscopic Ultrasound Examination Using EndoSound Vision System vs. Standard Echoendoscope
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pancreatic Disease
Pancreatic Cancer
Pancreatic Cyst
Gastrointestinal Tumor
Bile Duct Diseases
Bile Duct Cancer
Lymph Node Disease
Submucosal Tumor of Gastrointestinal Tract
Gastrointestinal Cancer
Keywords: Endoscopic ultrasound
EndoSound Vision System
Randomized trial
Lead sponsor: Orlando Health, Inc.
Sponsor class: OTHER
First posted: 2024-04-01
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief 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: 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.

Primary outcomes:
measure: Rate of successful completion of the requisite EUS examination
timeFrame: 1 day
Secondary outcomes:
measure: Ease of maneuverability of the device
timeFrame: 1 day
measure: Quality of EUS imaging
timeFrame: 1 day
measure: Ease of performing tissue acquisition
timeFrame: 1 day
measure: Diagnostic adequacy of procured specimen on onsite evaluation
timeFrame: 7 days
measure: Diagnostic adequacy of procured specimen in cell block
timeFrame: 7 days
measure: Diagnostic accuracy of procured specimen
timeFrame: 7 days
measure: Procedure duration
timeFrame: 1 day
measure: Rate of procedure-related adverse events
timeFrame: 7 days
measure: Procedure costs
timeFrame: 7 days
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Orlando Health
state: Florida
Study officials:
affiliation: Orlando Health, Digestive Health Institute
name: Ji Young Bang, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: