EUS Examination Using EndoSound Vision System vs. Standard Echoendoscope
Randomized Trial of Endoscopic Ultrasound Examination Using EndoSound Vision System vs. Standard Echoendoscope
1 other identifier
interventional
140
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2024
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 15, 2024
CompletedStudy Start
First participant enrolled
March 25, 2024
CompletedFirst Posted
Study publicly available on registry
April 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
April 1, 2024
March 1, 2024
2.7 years
March 15, 2024
March 25, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (9)
Ease of maneuverability of the device
1 day
Quality of EUS imaging
1 day
Ease of performing tissue acquisition
1 day
Diagnostic adequacy of procured specimen on onsite evaluation
7 days
Diagnostic adequacy of procured specimen in cell block
7 days
- +4 more secondary outcomes
Study Arms (2)
Standard echoendoscope
ACTIVE COMPARATORStandard echoendoscope will be used and EUS examination will be performed per standard of care.
EndoSound Vision System
ACTIVE COMPARATOREndoSound Vision System will be used and EUS examination will be performed per standard of care.
Interventions
Endoscopic ultrasound examination will be performed.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Age \< 18 years.
- Unable to obtain consent for the procedure from either the patient or LAR.
- Intrauterine pregnancy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Orlando Health
Orlando, Florida, 32806, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ji Young Bang, MD MPH
Orlando Health, Digestive Health Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2024
First Posted
April 1, 2024
Study Start
March 25, 2024
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2027
Last Updated
April 1, 2024
Record last verified: 2024-03