dMRI-1: Diffusion MRI-1 Imaging Database

Sponsor
Medtronic Spinal and Biologics (Industry)
Overall Status
Completed
CT.gov ID
NCT03775694
Collaborator
(none)
299
6
34.8
49.8
1.4

Study Details

Study Description

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 Phase
  • Device: dMRI Scan

Study Design

Study Type:
Observational
Actual Enrollment :
299 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
Diffusion MRI-1 Imaging Database
Actual Study Start Date :
Jun 6, 2019
Actual Primary Completion Date :
Apr 29, 2022
Actual Study Completion Date :
Apr 29, 2022

Outcome Measures

Primary Outcome Measures

  1. Image assessment [Procedure]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Colorado Aurora Colorado United States 80045
2 University of Florida Gainesville Florida United States 32611
3 Seattle Children's Hospital Seattle Washington United States 98101
4 University of Calgary Calgary Alberta Canada T2N 1N4
5 The Hospital for Sick Children Toronto Ontario Canada M5G 1X8
6 University of Sherbrooke Sherbrooke Quebec Canada J1H 5N4

Sponsors and Collaborators

  • Medtronic Spinal and Biologics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Medtronic Spinal and Biologics
ClinicalTrials.gov Identifier:
NCT03775694
Other Study ID Numbers:
  • MDT17084
First Posted:
Dec 14, 2018
Last Update Posted:
May 4, 2022
Last Verified:
May 1, 2022
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:

Study Results

No Results Posted as of May 4, 2022