NCT02266459

Brief Summary

This is a prospective, open, multicenter study that will enroll patients admitted to and hospitalized at the Stroke Unit due to diagnosed stroke and healthy volunteers. The main purpose of the study is to evaluate the ability of the Microwave Technology to deliver adequate measurement data.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
165

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Oct 2014

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

3 active sites

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

October 1, 2014

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

October 13, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 17, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

August 11, 2015

Status Verified

August 1, 2015

Enrollment Period

9 months

First QC Date

October 13, 2014

Last Update Submit

August 10, 2015

Conditions

StrokeHealthy

Outcome Measures

Primary Outcomes (1)

  • Ability to deliver adequate measurement data

    To confirm that the device will deliver adequate measurement data for at least 80 % of the patients diagnosed with Hemorrhagic stroke and Ischemic stroke

    The procedure will take approximately 15 minutes

Secondary Outcomes (4)

  • To confirm that the device will deliver adequate measurement data for at least 80 % of the healthy volunteers

    The procedure will take approximately 15 minutes

  • Mean time (± standard deviation) needed to complete the measurement procedure for group A + B + C

    The procedure will take approximately 15 minutes

  • To confirm the diagnostic ability of the device using a leave-one-out cross validation method

    The procedure will take approximately 15 minutes

  • Occurrence of adverse events

    24 hours

Interventions

Microwave technology (Medfield Diagnostics)DEVICE

A microwave measurement will be performed. The procedure will take approximately 15 minutes (the duration of the actual measurements is \< 1 minute) and will not interfere with the patient's standard of care at the Stroke Unit.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (Group A)
  • Signed Informed Consent Form
  • Patient diagnosed (by CT) with ischemic stroke, within 24 hours of stroke onset
  • Patient should be ≥ 18 years of age
  • (Group B)
  • Signed Informed Consent Form
  • Patient diagnosed (by CT) with hemorrhagic stroke, within 48 hours of stroke onset
  • Patient should be ≥ 18 years of age
  • (Group C)
  • Signed Informed Consent Form
  • Subject should be ≥ 18 years of age

You may not qualify if:

  • (Group A+B)
  • Pregnant or nursing woman
  • Woman of child bearing potential and not taking adequate contraceptive precautions
  • Patient that has already received thrombolytic treatment
  • Patient participating in any other clinical study that could interfere with the result in the present study
  • Patient diagnosed with a condition associated with risk of poor protocol compliance
  • Any other condition or symptoms preventing the patient from entering the study, according to the investigator´s judgment
  • Any patient that according to the Declaration of Helsinki is deemed unsuitable for study enrollment
  • (Group C)
  • Pregnant or nursing woman
  • Woman of child bearing potential and not taking adequate contraceptive precautions
  • Subject participating in any other clinical study that could interfere with the result in the present study
  • Any other condition or symptoms preventing the subject from entering the study, according to the investigator´s judgment
  • Any subject that according to the Declaration of Helsinki is deemed unsuitable for study enrolment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Strokeenheten, Södra Älvsborgs Sjukhus

Borås, Borås, 501 82, Sweden

Location

Sahlgrenska University Hospital/Sahlgrenska, Dept. of Neurology

Gothenburg, Göteborg, 41345, Sweden

Location

Strokeenheten, Skaraborgs Sjukhus

Skövde, 541 42, Sweden

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Jan-Erik Karlsson, MD, PhD

    Sahlgrenska University hospital/Sahlgrenska, Dept. of Neurology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2014

First Posted

October 17, 2014

Study Start

October 1, 2014

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

August 11, 2015

Record last verified: 2015-08

Locations

SE(3)