Comparing EndoSound Vision System to Standard Echoendoscope for EUS

This study is comparing a new device called the EndoSound Visual System to the standard echoendoscope (a special endoscope with an ultrasound probe) for performing endoscopic ultrasound (EUS) examinations. EUS is a procedure used to look at and take samples from areas like the pancreas, bile duct, and other parts of the digestive system. The EndoSound Visual System attaches to a regular endoscope, turning it into an echoendoscope. Researchers want to see if the EndoSound Visual System can successfully complete the EUS examination as well as the standard echoendoscope. You might be able to join if you are at least 18 years old and need an EUS for conditions like pancreatic disease, pancreatic cancer, or other gastrointestinal issues. The study is currently recruiting 140 participants, but its overall status is unclear.

Study design
This is a randomized study comparing two different devices for endoscopic ultrasound. It plans to enroll 140 participants.
What's involved
You would undergo an endoscopic ultrasound examination using either the standard echoendoscope or the EndoSound Visual System.
Compensation
Not stated in the trial record.
Follow-up
The main goal of the study is measured at 1 day after the procedure.

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NCT06340620

EUS Examination Using EndoSound Vision System vs. Standard Echoendoscope

Recruiting
NAAges 18+InterventionalDiagnostic
Orlando Health, Inc.
~140 participants
Updated 2024-04-01 on ClinicalTrials.gov
What's tested:Endoscopic ultrasound examination

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of successful completion of the requisite EUS examination
Measured over 1 day
Pancreatic Disease
Pancreatic Cancer
Pancreatic Cyst
Gastrointestinal Tumor
Bile Duct Diseases
Bile Duct Cancer
Lymph Node Disease
Submucosal Tumor of Gastrointestinal Tract
Gastrointestinal Cancer
1 sites across 1 states
Florida1
  • Ji Young Bang, MD MPH · PRINCIPAL_INVESTIGATOR · Orlando Health, Digestive Health Institute

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Eligibility criteria

Inclusion

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

Age \< 18 years.
Unable to obtain consent for the procedure from either the patient or LAR.
Intrauterine pregnancy.
  • Rate of successful completion of the requisite EUS examination1 day

    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.