Study for the Detection of Duodenal Papilla Using Capsule Endoscopy and Comparison of Images With EUS/ERCP Procedure.
NCT ID: NCT03685903
Last Updated: 2020-05-29
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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UNKNOWN
PHASE1
200 participants
INTERVENTIONAL
2018-09-26
2020-09-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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CapsoCam® Plus (SV-3) capsule endoscope
Endoscope Capsule
CapsoCam® Plus (SV-3) capsule endoscope
Endoscope Capsule
Interventions
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CapsoCam® Plus (SV-3) capsule endoscope
Endoscope Capsule
Eligibility Criteria
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Inclusion Criteria
* Provided written HIPAA Informed Consent in the IRB approved language.
* Patients indicated for periampullary or pancreaticobiliary examination, with prior cross-sectional imaging (CT/MRI/US/other) performed within past 6 months.
Exclusion Criteria
1. Patient refusal to undergo procedure, unstable cardiopulmonary, neurologic, or cardiovascular status; existing bowel perforation
2. Structural abnormalities of esophagus, stomach, small intestine at the discretion of physician.
2. Medical history of receipt of surgery, oncologic therapy, or radiation therapy who, in the opinion of the investigator, are at greater risk of capsule endoscope retention.
3. Any other contra-indicated condition as noted on the CapsoCam® Plus (SV-3) Instructions for Use, package insert.
18 Years
ALL
No
Sponsors
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Capso Vision, Inc.
INDUSTRY
Responsible Party
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Locations
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University of Utah
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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CLN-CVI-4801
Identifier Type: -
Identifier Source: org_study_id
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