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
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Epilepsy
• Healthy
• Other
• Tumor

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