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Chronic Subdural HematomaNCT02282228

Detecting Chronic Subdural Hematoma With Microwave Technology

A study testing Medfield Strokefinder MD100 in people with Chronic Subdural Hematoma and Healthy Volunteers, run by Sahlgrenska University Hospital at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Chronic Subdural Hematoma, Healthy Volunteers
What is being tested?
Medfield Strokefinder MD100
Type of treatment
Medical device
How many people
41 participants
Where
1 siteSweden
Study dates
Nov 2014to Jan 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Sahlgrenska University Hospital, Department of Neurosurgery

    Gothenburg, Västra Götaland County, 413 45

Other trials in Sweden

About this study

Official title: Detecting Chronic Subdural Hematoma With Microwave Technology - An Open Study Evaluating the Sensitivity and Specificity of a Microwave-based Device, Medfield Strokefinder MD100, to Detect Chronic Subdural Hematoma

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.

Read the detailed description

This open study will enroll patients admitted for surgery of chronic subdural hematoma at the Department of Neurosurgery at Sahlgrenska University Hospital and compare them to measurements of healthy volunteers. Patients will be asked to participate in the study, as early as possible after admission. After physical examination, checking the inclusion/exclusion criteria, and after informed consent has been acquired, the microwave-based measurement will be performed. The diagnostic procedure is estimated to take 30 min whereof total subject measurement time will be less than five minutes. Healthy volunteers will be recruited in parallel and the same procedure as for the patients will be followed.

Safety will be followed throughout the study, and a safety follow-up will be performed 12 hours after the microwave-based investigation is finalized.

To avoid measurement bias all measurements, for both patients and healthy volunteers, will be performed by the same operator.

Being tested
Medfield Strokefinder MD100
Medical subject headings
Hematoma, Subdural, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Medfield Strokefinder MD100Device

    Measurement with Medfield Strokefinder MD100.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: The diagnostic procedure has an estimated duration of 30 minutes.

Secondary outcomes (3)

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

    Pearson's linear correlation coefficient is calculated by comparing subdural hematoma volumes estimated by analysis of CT image and by a mathematical analysis of the microwave data.

    Measured: The diagnostic procedure has an estimated duration of 30 minutes.

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

    The ability of the device to estimate location of subdural hematoma is evaluated using a classification algorithm and leave-one-out cross validation.

    Measured: The diagnostic procedure has an estimated duration of 30 minutes.

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

    Measured: The diagnostic procedure has an estimated duration of 30 minutes.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2014 (estimated)
  2. Study startNov 2014
  3. Primary completionJan 2016
  4. Study completionJan 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02282228
Sponsor's protocol ID
CSH 01
Status last verified
Aug 2018
First submitted
22 Oct 2014
Last updated
23 Aug 2018
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 28287909

Questions about this trial

What is this clinical trial studying?

A study testing Medfield Strokefinder MD100 in people with Chronic Subdural Hematoma and Healthy Volunteers, run by Sahlgrenska University Hospital at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sensitivity and specificity for distinguishing chronic subdural hematoma patients from healthy volunteers using a classification algorithm. (time frame: The diagnostic procedure has an estimated duration of 30 minutes.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02282228, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2018.

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