NCT02942667

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2016

Completed
24 days until next milestone

First Posted

Study publicly available on registry

October 24, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 6, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2018

Completed
Last Updated

February 7, 2018

Status Verified

February 1, 2018

Enrollment Period

1.3 years

First QC Date

September 30, 2016

Last Update Submit

February 6, 2018

Conditions

Volunteers

Outcome Measures

Primary Outcomes (1)

  • Collect High Quality MRI Data

    Approximately 6 Weeks

Study Arms (1)

Subjects undergoing high quality MRI Scans

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study will enroll up to 30 subjects at up to 5 study sites in the US.

You may qualify if:

  • Subject is at least 18 years of age
  • Subject is willing and able to undergo study requirements

You may not qualify if:

  • 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
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Winston-Salem, North Carolina, United States

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2016

First Posted

October 24, 2016

Study Start

August 1, 2016

Primary Completion

December 6, 2017

Study Completion

February 2, 2018

Last Updated

February 7, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)