EUS Examination Using EndoSound Vision System vs. Standard Echoendoscope
Purpose
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.
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
Eligibility
- Eligible Ages
- Between 18 Years and 100 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover Assignment
- Primary Purpose
- Diagnostic
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Standard echoendoscope |
Standard echoendoscope will be used and EUS examination will be performed per standard of care. |
|
|
Active Comparator EndoSound Vision System |
EndoSound Vision System will be used and EUS examination will be performed per standard of care. |
|
Recruiting Locations
Orlando, Florida 32806
More Details
- Status
- Recruiting
- Sponsor
- Orlando Health, Inc.
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.