Trial Outcomes & Findings for Magnetic Resonance Imaging Using Innovative Pulse Sequences (NCT NCT01724216)

Results Overview

Collect head human images and associated technical and clinical information to demonstrate neurological magnetic resonance imaging of subjects using short pulse sequence.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

11 participants

Primary outcome timeframe

6-months

Results posted on

2015-11-18

Participant Flow

Subjects with orders from their doctor for an MRI were screened from Spectrum Health's Neurology Department. The study coordinator contacts each subject that met the inclusion criteria. If the subject is interested to volunteer, a copy of the Informed Consent was sent and appointment scheduled. Seg. 1 enrolled 11 subjects; no Seg. 2 enrollment.

This is a single arm study.

Participant milestones

Participant milestones
Measure	Single Arm Magnetic Resonance Images Collected Using Innovative Pulse Sequences :
Overall Study STARTED	11
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Single Arm Magnetic Resonance Images Collected Using Innovative Pulse Sequences :
Overall Study Scan was not completed	1

Baseline Characteristics

Magnetic Resonance Imaging Using Innovative Pulse Sequences

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Arm n=10 Participants Magnetic Resonance Image Collection Using Innovative Pulse Sequences
Age, Customized <=18 years	0 participants with images collected n=5 Participants
Age, Customized Between 18 and 65 years	10 participants with images collected n=5 Participants
Age, Customized >=65 years	0 participants with images collected n=5 Participants
Sex/Gender, Customized	NA participants with images collected n=5 Participants
Region of Enrollment United States	10 particpants with images collected n=5 Participants

PRIMARY outcome

Timeframe: 6-months

Collect head human images and associated technical and clinical information to demonstrate neurological magnetic resonance imaging of subjects using short pulse sequence.

Outcome measures

Outcome measures
Measure	Single Arm n=10 Images Magnetic Resonance Imaging Using Innovative Pulse Sequences :
Number of Head Images Successfully Collected	10 Images

Adverse Events

Single Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mark Charles DeLano, M.D., Principal Investigator

Spectrum Health

Phone: 616-363-7339

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place