- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02707289
Retrospective Collection of PillCam SB Movies (OCEAN)
July 6, 2018 updated by: Medtronic - MITG
Retrospective Collection of PillCam SB Movies for Capsule Transit Time Analysis (OCEAN Study)
Up to two hundred un-identified PillCam SB movies will be collected from 2 clinical sites, during up to 3 years and transferred to Given Imaging.
Demographical data and medical history will be collected.
Capsule transit time in the different sections of the GI will be evaluated.
Study Overview
Status
Completed
Conditions
Detailed Description
Up to two hundred un-identified PillCam SB movies that were created between the year 2008 and the date the study was approved by the IRB, will be collected from 2 clinical sites, Sourasky and Sheba medical centers during up to 3 years and transferred to Given Imaging.
Demographical data and medical history will be collected.
Capsule transit time in the different sections of the GI will be evaluated by internal readers.
Study Type
Observational
Enrollment (Actual)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ramat-Gan, Israel, 52621
- Sheba Medical Center
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Tel-Aviv, Israel, 64239
- The Tel-Aviv Sourasky Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Up to two hundred un-identified PillCam SB movies that were created between the year 2008 and the date the study was approved by the IRB, will be collected
Description
Inclusion Criteria:
Videos collected from any PillCam SB procedure
Exclusion Criteria:
None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Transit time in the different sections of the GI according to PillCam SB movies (minutes)
Time Frame: Minutes
|
Minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2016
Primary Completion (Actual)
June 18, 2018
Study Completion (Actual)
June 18, 2018
Study Registration Dates
First Submitted
March 2, 2016
First Submitted That Met QC Criteria
March 8, 2016
First Posted (Estimate)
March 14, 2016
Study Record Updates
Last Update Posted (Actual)
July 9, 2018
Last Update Submitted That Met QC Criteria
July 6, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- COVGIBD0547
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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