Magnetic Resonance Imaging of Human Biometrics

Volunteers Clinical Trial

— MRI HB  

Official title:

Magnetic Resonance Imaging of Human Biometrics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02942667
• Other study ID #: MRI HB
• Status: Completed
• Phase: N/A
• First received: September 30, 2016
• Last updated: February 6, 2018
• Start date: August 2016
• Est. completion date: February 2, 2018

Study information

• Verified date: February 2018
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The primary objective is to collect high quality MRI data (un-processed or processed) from participating subjects for Medtronic research purposes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 2, 2018
• Est. primary completion date: December 6, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject is at least 18 years of age

• Subject is willing and able to undergo study requirements

Exclusion Criteria:

• Subject has a medical condition that precludes the subject from participation

• Subject has any magnetizable foreign object (e.g. jewelry) which cannot be removed for the duration of the study

• Subject is claustrophobic

• Subject is unable to stand without assistance

• Subject requires sedation for MRI scans

• Subject is implanted with non-Magnetic Resonance conditional or other medical device:

• Non-MRI conditional pacemaker, Implantable Cardiac Defibrillator (ICD), Cardiac Resynchronization Therapy (CRT), or an implantable hemodynamic monitor

• Metal clips (i.e. brain aneurysm clip)

• Artificial heart valve

• Implanted neural stimulator

• Gastric capsule camera

• Swan Ganz catheter

• Stent

• Inferior Vena Cava (IVC) filter

• Orthopedic implant

• Eye prosthesis

• Vascular access port

• Penile prosthesis

• Intrauterine device

• Subject has a cochlear implant, middle ear prosthesis, or has had ear surgery

• Subject has ocular foreign bodies (i.e. metal shavings)

• Subject has any type of device held in place by a magnet (i.e. dentures)

• Subject has an insulin pump

• Subject has metal shrapnel

• Subject is pregnant or lactating

• Subject has magnetizable implant

• Subject requires legally authorized representative to sign Patient Informed Consent (PIC)/ Informed Consent (IC) form

• Subject has other contraindication for an MRI scan as defined by the study site

Related Conditions & MeSH terms

• Volunteers

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Collect High Quality MRI Data		Approximately 6 Weeks