- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03775694
Diffusion MRI-1 Imaging Database (dMRI-1)
May 3, 2022 updated by: Medtronic Spinal and Biologics
The purpose of the dMRI-1 data collection study is to establish a database of clinical images and limited medical history information from patients that have previously received a dMRI scan.
All data collected will be de-identified.
No safety or effectiveness assessments will be completed.
Study Overview
Study Type
Observational
Enrollment (Actual)
299
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
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Alberta
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Calgary, Alberta, Canada, T2N 1N4
- University of Calgary
-
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Ontario
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Toronto, Ontario, Canada, M5G 1X8
- The Hospital for Sick Children
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-
Quebec
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Sherbrooke, Quebec, Canada, J1H 5N4
- University of Sherbrooke
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-
-
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Colorado
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Aurora, Colorado, United States, 80045
- University of Colorado
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Florida
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Gainesville, Florida, United States, 32611
- University of Florida
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Washington
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Seattle, Washington, United States, 98101
- Seattle Children's Hospital
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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
Patients who have previously received a dMRI scan.
Description
Inclusion Criteria:
- Patient is either ≥ 18 years and has previously received an acceptable dMRI scan(s) with at least 30 unique gradient directions or < 18 years who has previously received an acceptable dMRI scan of any number of unique gradient directions and who is allowed to participate in this type of research project (e.g., IRB/EC approval with waiver of consent) per IRB/EC
- Acceptable dMRI scan was completed prior to site activation in the study
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
- Observational Models: Case-Only
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Image assessment
Time Frame: Procedure
|
Procedure
|
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)
June 6, 2019
Primary Completion (Actual)
April 29, 2022
Study Completion (Actual)
April 29, 2022
Study Registration Dates
First Submitted
December 12, 2018
First Submitted That Met QC Criteria
December 12, 2018
First Posted (Actual)
December 14, 2018
Study Record Updates
Last Update Posted (Actual)
May 4, 2022
Last Update Submitted That Met QC Criteria
May 3, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MDT17084
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
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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