NCT02490306

Brief Summary

This is a prospective, open, multicentre trial that will enrol patients with clinical signs of stroke in the acute phase admitted for CT scan. Follow-up microwave measurements will be performed after the acute phase. The study assesses the diagnostic capability and safety of Strokefinder MD100.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Jul 2015

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

June 29, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 3, 2015

Completed
8.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

October 28, 2022

Status Verified

October 1, 2022

Enrollment Period

8.4 years

First QC Date

June 29, 2015

Last Update Submit

October 27, 2022

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

  • The diagnostic ability as measured by the area under receiver operating characteristic curve (AUC) of the device for patient group A vs. group B, using the leave-one-out cross validation (LOOCV) method

    The diagnostic procedure will take less than 5 minutes

Secondary Outcomes (2)

  • The diagnostic ability as measured by the AUC of the device for patient group C vs. groups A + B, using the LOOCV method

    The diagnostic procedure will take less than 5 minutes

  • Any adverse events occurring within 24 hours from the measurement procedure(s)

    Within 24 hours

Study Arms (3)

Hemorrhagic stroke

EXPERIMENTAL

Patient group A is defined as patients that are diagnosed with hemorrhagic stroke. Interventions: Strokefinder MD100 measurement

Device: Strokefinder MD100 measurement

Ischemic stroke

EXPERIMENTAL

Patient group B is defined as patients that are diagnosed with ischemic stroke. Interventions: Strokefinder MD100 measurement

Device: Strokefinder MD100 measurement

Stroke mimics

EXPERIMENTAL

Patient group C is defined as patients with stroke mimics, i.e. with initially suspected stroke but not diagnosed with stroke. Interventions: Strokefinder MD100 measurement

Device: Strokefinder MD100 measurement

Interventions

Strokefinder MD100 measurementDEVICE

A microwave measurement will be performed with the patient lying in the hospital bed or another suitable surface. Follow-up microwave measurements will be performed after the acute phase.

Hemorrhagic strokeIschemic strokeStroke mimics

Eligibility Criteria

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

You may qualify if:

  • Patient should be ≥ 18 years of age
  • Patient has clinical signs of stroke
  • Patient/next of kin confirms orally that the patient wants to participate in the trial (during acute phase)
  • Signed Informed Consent Form (after acute phase)

You may not qualify if:

  • Pregnant or nursing woman
  • Fertile woman where pregnancy cannot be excluded
  • Patient diagnosed with a condition associated with risk of poor protocol compliance
  • The diagnostic procedure is deemed to interfere with the standard of care
  • 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 enrolment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska University Hospital, Stroke Unit

Gothenburg, Västra Götaland County, 413 45, Sweden

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Mikael Elam, PhD, MD

    Sahlgrenska University Hospital, Department of Clinical Neurophysiology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mikael Elam, PhD, MD

CONTACT

+46(0)70-940 10 42mikael.elam@neuro.gu.se

Stefan J Candefjord, PhD

CONTACT

+46(0)73-382 15 37stefan.candefjord@chalmers.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, MD

Study Record Dates

First Submitted

June 29, 2015

First Posted

July 3, 2015

Study Start

July 1, 2015

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

October 28, 2022

Record last verified: 2022-10

Locations

SE(1)