EUS Examination Using EndoSound Vision System vs. Standard Echoendoscope

Part of paid clinical trials in Orlando, Florida.

Sponsor
Orlando Health, Inc.
Study ID
NCT06340620
Status
Recruiting
Apply to this trial

Conditions

  • Bile Duct Cancer
  • Bile Duct Diseases
  • Gastrointestinal Cancer
  • Gastrointestinal Tumor
  • Lymph Node Disease
  • Pancreatic Cancer
  • Pancreatic Cyst
  • Pancreatic Disease
  • Submucosal Tumor of Gastrointestinal Tract

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Endoscopic ultrasound examination — DEVICE
    Endoscopic ultrasound examination will be performed.

Study Details

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.

Key Dates

Start date
Mar 25, 2024
Status verified
Mar 2024
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
140 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC

Arms

  • 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.

Primary Outcome Measure

Rate of successful completion of the requisite EUS examination [ Time Frame: 1 day ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Orlando HealthOrlandoFlorida32806
Ji Young Bang, MD MPH
[email protected]
321-841-2431
Barbara Broome
[email protected]
321-841-4356

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Orlando Health· Orlando, FL

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