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Diffusion MRI-1 Imaging Database (dMRI-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03775694
Recruitment Status : Recruiting
First Posted : December 14, 2018
Last Update Posted : July 30, 2020
Sponsor:
Information provided by (Responsible Party):
Medtronic Surgical Technologies

Brief Summary:
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.

Condition or disease Intervention/treatment
Epilepsy Tumor Healthy Other Device: dMRI Scan

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Diffusion MRI-1 Imaging Database
Actual Study Start Date : June 6, 2019
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : January 31, 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: dMRI Scan
    Data will be collected from cases where dMRI scans were obtained as part of the subject's previous treatment.


Primary Outcome Measures :
  1. Image assessment [ Time Frame: Procedure ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients who have previously received a dMRI scan.
Criteria

Inclusion Criteria:

  1. 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
  2. Acceptable dMRI scan was completed prior to site activation in the study

Exclusion Criteria:

None


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03775694


Contacts
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Contact: Robert Wroblewski 763-526-1368 robert.k.wroblewski@medtronic.com

Locations
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United States, Colorado
University of Colorado Active, not recruiting
Aurora, Colorado, United States, 80045
United States, Florida
University of Florida Not yet recruiting
Gainesville, Florida, United States, 32611
Contact: Jessica Smith         
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98101
Contact: Gloria Bowen         
Canada, Alberta
University of Calgary Not yet recruiting
Calgary, Alberta, Canada, T2N 1N4
Contact: Perry Radau, PhD         
Canada, Ontario
The Hospital for Sick Children Active, not recruiting
Toronto, Ontario, Canada, M5G 1X8
Canada, Quebec
University of Sherbrooke Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Contact: Amelie Tetu         
Sponsors and Collaborators
Medtronic Surgical Technologies
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Responsible Party: Medtronic Surgical Technologies
ClinicalTrials.gov Identifier: NCT03775694    
Other Study ID Numbers: MDT17084
First Posted: December 14, 2018    Key Record Dates
Last Update Posted: July 30, 2020
Last Verified: July 2020

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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
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases