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NCT03775694 Clinical Trial

Diffusion MRI-1 Imaging Database

Healthy Clinical Trial

— dMRI-1  

Official title:
Diffusion MRI-1 Imaging Database

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03775694
Other study ID # MDT17084
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 6, 2019
Est. completion date April 29, 2022

Study information
Verified date May 2022
Source Medtronic Spinal and Biologics
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 299
Est. completion date April 29, 2022
Est. primary completion date April 29, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Canada University of Calgary Calgary Alberta
Canada University of Sherbrooke Sherbrooke Quebec
Canada The Hospital for Sick Children Toronto Ontario
United States University of Colorado Aurora Colorado
United States University of Florida Gainesville Florida
United States Seattle Children's Hospital Seattle Washington

Sponsors (1)
Lead Sponsor Collaborator
Medtronic Spinal and Biologics

Countries where clinical trial is conducted

United States,  Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Image assessment Procedure
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