NCT02282228

Brief Summary

An open study evaluating the sensitivity and specificity of a microwave-based device, Medfield Strokefinder MD100, to detect chronic subdural hematoma, by comparing measurements on patients recruited for surgery of chronic subdural hematoma to an age- and gender-matched group of healthy volunteers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2014

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

First Submitted

Initial submission to the registry

October 22, 2014

Completed
10 days until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 4, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

August 23, 2018

Status Verified

August 1, 2018

Enrollment Period

1.2 years

First QC Date

October 22, 2014

Last Update Submit

August 21, 2018

Conditions

Chronic Subdural HematomaHealthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • Sensitivity and specificity for distinguishing chronic subdural hematoma patients from healthy volunteers using a classification algorithm.

    The diagnostic ability of the device is calculated using a leave-one-out cross-validation method.

    The diagnostic procedure has an estimated duration of 30 minutes.

Secondary Outcomes (3)

  • Correlation between subdural hematoma volumes estimated by CT and by mathematical analysis of microwave data.

    The diagnostic procedure has an estimated duration of 30 minutes.

  • Classification accuracy for estimating the position of the subdural hematoma through a mathematical analysis of the microwave data.

    The diagnostic procedure has an estimated duration of 30 minutes.

  • Mean (± standard deviation) signal amplitude and phase shift caused by presence of chronic subdural hematoma.

    The diagnostic procedure has an estimated duration of 30 minutes.

Interventions

Medfield Strokefinder MD100DEVICE

Measurement with Medfield Strokefinder MD100.

Eligibility Criteria

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

You may qualify if:

  • Patient admitted for surgery of chronic subdural hematoma.
  • A CT scan of the patient has been performed, within the latest 96 hours.
  • The patient should be able to have a normal conversation and understand the information about the study, corresponding to Glasgow Coma Scale (Verbal Response) of 5.
  • Patient/healthy volunteer should be ≥ 18 years of age.
  • The patient/healthy volunteer has signed a written informed consent.

You may not qualify if:

  • Females who are pregnant or breast feeding women.
  • Patient/healthy volunteer has a shunt or other foreign object implanted in the brain.
  • Patient/healthy volunteer participating in any other clinical study that could interfere with the result in the ongoing study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska University Hospital, Department of Neurosurgery

Gothenburg, Västra Götaland County, 413 45, Sweden

Location

Related Publications (1)

  • Ljungqvist J, Candefjord S, Persson M, Jonsson L, Skoglund T, Elam M. Clinical Evaluation of a Microwave-Based Device for Detection of Traumatic Intracranial Hemorrhage. J Neurotrauma. 2017 Jul 1;34(13):2176-2182. doi: 10.1089/neu.2016.4869. Epub 2017 Mar 13.

    PMID: 28287909RESULT

MeSH Terms

Conditions

Hematoma, Subdural, Chronic

Condition Hierarchy (Ancestors)

Hematoma, SubduralIntracranial Hemorrhage, TraumaticIntracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemVascular DiseasesCardiovascular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHematomaHemorrhageWounds and Injuries

Study Officials

  • Thomas Skoglund, MD, PhD

    Sahlgrenska University Hospital, Department of Neurosurgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 22, 2014

First Posted

November 4, 2014

Study Start

November 1, 2014

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

August 23, 2018

Record last verified: 2018-08

Locations

SE(1)