Orlando Health, Inc.
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.
Pancreatic Disease
Pancreatic Cancer
Pancreatic Cyst
Gastrointestinal Tumor
Bile Duct Diseases
Bile Duct Cancer
Lymph Node Disease
Submucosal Tumor of Gastrointestinal Tract
Gastrointestinal Cancer
Endoscopic ultrasound examination
NA
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.
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 140 participants |
| Masking : | TRIPLE |
| Primary Purpose : | DIAGNOSTIC |
| Official Title : | Randomized Trial of Endoscopic Ultrasound Examination Using EndoSound Vision System vs. Standard Echoendoscope |
| Actual Study Start Date : | 2024-03-25 |
| Estimated Primary Completion Date : | 2026-12 |
| Estimated Study Completion Date : | 2027-12 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years to 100 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
Orlando Health
Orlando, Florida, United States, 32806