Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2013-03-31
2013-06-30
Brief Summary
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The quality of imaging is of utmost importance for diagnosing early neoplasms in the pancreas and diseases such as chronic pancreatitis. Image quality is dictated by two factors: image resolution and depth of penetration. Good imaging enables diagnosis of early stage disease and thereby facilitates early treatment.
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Detailed Description
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In this study, the endoscopy during the procedure will be attached to two different processors and images will be generated. The choice of which processor will be used first will be at the discretion of the Endoscopist. This does not require removal and reintroduction of the endoscope into the patient at two occasions. Only the connector will be switched to a different processor. So there is negligible risk to the patient.
The time required for research activities will be between 5-10 minutes. Both processors will be set up in the procedure room for the duration of this study.
The physician will then document the depth of penetration of the image (the farthest structure seen) and image resolution (evaluating the pancreas for subtle abnormalities). Both processors will be used for each patient. The scores for each processor will be documented to a procedure log, using the primary endpoint described above. The CRF will not have any patient information. Images viewed by the physician at the time of procedure will not be saved or recorded as part of this study..
EUS will be performed in the standard fashion by one of the experienced endosonographers in the unit. Once the EUS is complete, the procedure will be stopped and the echoendoscope withdrawn from the patient.
Patients will then be transported to the recovery area for observation as per standard policy. After appropriate observations are deemed satisfactory, patients will be discharged as per unit policy.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Aloka
image quality and resolution
image quality and resolution
Image quality and resolution will be viewed using Aloka processor
image quality and resolution
image quality and resolution will be viewed on the EU-me2
Interventions
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image quality and resolution
Image quality and resolution will be viewed using Aloka processor
image quality and resolution
image quality and resolution will be viewed on the EU-me2
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
19 Years
89 Years
ALL
Yes
Sponsors
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AdventHealth
OTHER
Responsible Party
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Principal Investigators
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Shyam Varadarajulu, MD
Role: PRINCIPAL_INVESTIGATOR
AdventHealth
Locations
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Florida Hospital
Orlando, Florida, United States
Countries
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Other Identifiers
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409829
Identifier Type: -
Identifier Source: org_study_id
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