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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00481416
Registration number
NCT00481416
Ethics application status
Date submitted
30/05/2007
Date registered
1/06/2007
Date last updated
31/07/2019
Titles & IDs
Public title
"Evaluation of the PillCamâ„¢ESO Capsule in the Detection of Esophageal Varices
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Scientific title
Evaluation of the PillCamâ„¢ Eso Capsule in the Detection of Esophageal Varices
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Secondary ID [1]
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MA-37
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Universal Trial Number (UTN)
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Trial acronym
MA-37
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Esophageal Varices
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Condition category
Condition code
Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Cardiovascular
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0
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Devices - PillCam Eso
Treatment: Devices: PillCam Eso
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Eligibility
Key inclusion criteria
1. Patient has prior endoscopic confirmation of esophageal varices and is undergoing
surveillance endoscopy or
2. Patient has sign/symptoms of chronic liver disease, without previous diagnosis of
esophageal varices,with clinical indication to undergo esophagoscopy (or EGD)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Patient has difficulty swallowing
2. Patient has known Zenker's Diverticulum
3. Patient went through previous endoscopic treatment of esophageal varices
4. Patient is known or is suspected to suffer from intestinal obstruction
5. Patient has a cardiac pacemaker or other implanted electro medical device
6. Female patient is pregnant
7. Patient is expected to undergo MRI examination within 7 days after ingestion of the
capsule
8. Patient has had a prior abdominal surgery of the gastrointestinal tract (other than
uncomplicated appendectomy or uncomplicated cholecystectomy)
9. Patient has any condition, which precludes compliance with study and/or device
instructions
10. Patient suffers from life threatening conditions
11. Patient is currently participating in another clinical study -
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/12/2004
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/01/2005
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Sample size
Target
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Accrual to date
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Final
318
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Royal Brisbane and Women's Hospital - Herston
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Recruitment postcode(s) [1]
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4029 - Herston
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arizona
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Country [2]
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United States of America
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State/province [2]
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Minnesota
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Country [3]
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United States of America
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State/province [3]
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Oregon
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Country [4]
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Israel
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State/province [4]
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Haifa
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Medtronic - MITG
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Address
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Country
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Ethicon Endo-Surgery
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of the study is to access the accuracy of the PillCam Eso capsule in identifying
the presence of suspected esophageal disease in patients undergoing surveillance or screening
for esophageal disease by standard endoscopy
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00481416
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Glenn M Eisen, MD
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Address
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OHSU Portland, OR
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00481416
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