Inflammatory Bowel Disease, Crohn DiseaseOCEANNCT02707289
Retrospective Collection of PillCam SB Movies
An observational study of Inflammatory Bowel Disease, Crohn Disease, run by Medtronic - MITG at 2 sites in Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Inflammatory Bowel Disease, Crohn Disease
- How many people
- 20 participants
- Where
- 2 sitesIsrael
- Study dates
- May 2016to 18 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- Videos collected from any PillCam SB procedure
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Sheba Medical Center
Ramat Gan, 52621
The Tel-Aviv Sourasky Medical Center
Tel Aviv, 64239
About this study
Official title: 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.
Read the 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.
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Transit time in the different sections of the GI according to PillCam SB movies (minutes)
Measured: Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2016 (estimated)
- Study startMay 2016
- Primary completion18 Jun 2018
- Study completion18 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel Disease, Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by Medtronic - MITGThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Abraham Eliakim, Prof., Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02707289
- Sponsor's protocol ID
- COVGIBD0547
- Acronym
- OCEAN
- Status last verified
- Jul 2018
- First submitted
- 2 Mar 2016
- Last updated
- 9 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Collection of PillCam SB Movies for Capsule Transit Time Analysis (OCEAN Study)
- ClinicalTrials.gov ID
- NCT02707289
- Acronym / sponsor ID
- OCEAN / COVGIBD0547
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- May 2016 (actual)
- Primary completion
- 18 Jun 2018 (actual)
- Study completion
- 18 Jun 2018 (actual)
- First posted
- 14 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Videos collected from any PillCam SB procedure
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Transit time in the different sections of the GI according to PillCam SB movies (minutes)
Time frame: Minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abraham Eliakim, Prof. principal investigator
Sheba Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Disease, Crohn Disease, run by Medtronic - MITG at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transit time in the different sections of the GI according to PillCam SB movies (minutes) (time frame: Minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2018.