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2024-03-25
2026-12
2027-12
140
NCT06340620
Orlando Health, Inc.
Orlando Health, Inc.
INTERVENTIONAL
EUS Examination Using EndoSound Vision System vs. Standard Echoendoscope
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2024-03-15 | N/A | 2024-03-25 |
2024-03-25 | N/A | 2024-04-01 |
2024-04-01 | N/A | 2024-03 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Diagnostic
Allocation:
Randomized
Interventional Model:
Crossover
Masking:
Triple
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| ACTIVE_COMPARATOR: Standard echoendoscope Standard echoendoscope will be used and EUS examination will be performed per standard of care. | DEVICE: Endoscopic ultrasound examination
|
| ACTIVE_COMPARATOR: EndoSound Vision System EndoSound Vision System will be used and EUS examination will be performed per standard of care. | DEVICE: Endoscopic ultrasound examination
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Rate of successful completion of the requisite EUS examination | 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. | 1 day |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Ease of maneuverability of the device | The ease of maneuverability during EUS between the EndoSound Vision System and standard echoendoscopes will be assessed, based on a rating scale of 1 to 5 (whereby 1 is the most easy to maneuver and 5 is the most difficult to maneuver). | 1 day |
| Quality of EUS imaging | The quality of EUS imaging during EUS between the EndoSound Vision System and standard echoendoscopes will be assessed, based on a rating scale of 1 to 5 (whereby 1 is the best quality imaging and 5 is the worst quality imaging). | 1 day |
| Ease of performing tissue acquisition | The ease of performing tissue acquisition during EUS between the EndoSound Vision System and standard echoendoscopes will be assessed, based on a rating scale of 1 to 5 (whereby 1 is the most easy to perform and 5 is the most difficult to perform). | 1 day |
| Diagnostic adequacy of procured specimen on onsite evaluation | Rate of diagnostic adequacy of procured tissue specimen on onsite evaluation between the EndoSound Vision System and standard echoendoscopes. | 7 days |
| Diagnostic adequacy of procured specimen in cell block | Rate of diagnostic adequacy of procured tissue specimen in cell block between the EndoSound Vision System and standard echoendoscopes. | 7 days |
| Diagnostic accuracy of procured specimen | Rate of diagnostic accuracy of procured tissue specimen between the EndoSound Vision System and standard echoendoscopes. | 7 days |
| Procedure duration | Duration of procedure between the EndoSound Vision System and standard echoendoscopes. | 1 day |
| Rate of procedure-related adverse events | Rate of procedure-related adverse events between the EndoSound Vision System and standard echoendoscopes. | 7 days |
| Procedure costs | Costs associated with the endoscopic ultrasound procedures between the EndoSound Vision System and standard echoendoscopes. | 7 days |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Ji Young Bang, MD MPH Phone Number: 321-841-2431 Email: jiyoung.bang@orlandohealth.com |
Study Contact Backup Name: Barbara Broome Phone Number: 321-841-4356 Email: barbara.broome@orlandohealth.com |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
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