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Trial Title:
EUS Examination Using EndoSound Vision System vs. Standard Echoendoscope
NCT ID:
NCT06340620
Condition:
Pancreatic Disease
Pancreatic Cancer
Pancreatic Cyst
Gastrointestinal Tumor
Bile Duct Diseases
Bile Duct Cancer
Lymph Node Disease
Submucosal Tumor of Gastrointestinal Tract
Gastrointestinal Cancer
Conditions: Official terms:
Gastrointestinal Neoplasms
Bile Duct Neoplasms
Cholangiocarcinoma
Digestive System Neoplasms
Pancreatic Cyst
Pancreatic Diseases
Bile Duct Diseases
Conditions: Keywords:
Endoscopic ultrasound
EndoSound Vision System
Randomized trial
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Crossover Assignment
Primary purpose:
Diagnostic
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Intervention:
Intervention type:
Device
Intervention name:
Endoscopic ultrasound examination
Description:
Endoscopic ultrasound examination will be performed.
Arm group label:
EndoSound Vision System
Arm group label:
Standard echoendoscope
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
100 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Orlando Health
Address:
City:
Orlando
Zip:
32806
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ji Young Bang, MD MPH
Phone:
321-841-2431
Email:
jiyoung.bang@orlandohealth.com
Contact backup:
Last name:
Barbara Broome
Phone:
321-841-4356
Email:
barbara.broome@orlandohealth.com
Start date:
March 25, 2024
Completion date:
December 2027
Lead sponsor:
Agency:
Orlando Health, Inc.
Agency class:
Other
Source:
Orlando Health, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06340620
