EUS Examination Using EndoSound Vision System vs. Standard Echoendoscope
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Endoscopic ultrasound examination.
- Who it may be relevant to
- Registry conditions: Pancreatic Disease, Pancreatic Cancer, Pancreatic Cyst, Gastrointestinal Tumor. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Randomized Trial of Endoscopic Ultrasound Examination Using EndoSound Vision System vs. Standard Echoendoscope
Overview
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.
Interventions
- Device Endoscopic ultrasound examination
Endoscopic ultrasound examination will be performed.
Primary outcome measures
- Rate of successful completion of the requisite EUS examination [Time frame: 1 day]
Secondary outcome measures (9)
- Ease of maneuverability of the device [Time frame: 1 day]
- Quality of EUS imaging [Time frame: 1 day]
- Ease of performing tissue acquisition [Time frame: 1 day]
- Diagnostic adequacy of procured specimen on onsite evaluation [Time frame: 7 days]
- Diagnostic adequacy of procured specimen in cell block [Time frame: 7 days]
- Diagnostic accuracy of procured specimen [Time frame: 7 days]
- Procedure duration [Time frame: 1 day]
- Rate of procedure-related adverse events [Time frame: 7 days]
- Procedure costs [Time frame: 7 days]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Triple blind
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Orlando Health — Orlando
Identifiers
NCT: NCT06340620 · 24.017.01