Trials / Recruiting
RecruitingNCT06340620
EUS Examination Using EndoSound Vision System vs. Standard Echoendoscope
Randomized Trial of Endoscopic Ultrasound Examination Using EndoSound Vision System vs. Standard Echoendoscope
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 140 (estimated)
- Sponsor
- Orlando Health, Inc. · Academic / Other
- Sex
- All
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Not accepted
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.
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Endoscopic ultrasound examination | Endoscopic ultrasound examination will be performed. |
Timeline
- Start date
- 2024-03-25
- Primary completion
- 2026-12-01
- Completion
- 2027-12-01
- First posted
- 2024-04-01
- Last updated
- 2024-04-01
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06340620. Inclusion in this directory is not an endorsement.