Traumatic Intracranial HemorrhageNCT02728908
Detecting Traumatic Intracranial Hemorrhage With Microwave Technology
A study testing Medfield Strokefinder MD100 in people with Traumatic Intracranial Hemorrhage, run by Hans Granhed at 1 site in Sweden.
Trial summary
An open study evaluating the diagnostic accuracy of a microwave-based device to detect traumatic intracranial hemorrhage (TICH), by comparing measurements on trauma patients with confirmed vs excluded TICH Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Intracranial Hemorrhage
- What is being tested?
- Medfield Strokefinder MD100
- Type of treatment
- Medical device
- How many people
- 250 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2016to 1 Nov 2019
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient admitted to Sahlgrenska University Hospital for trauma care.
- Patient deemed clinically stable.
- Patient should have a Glasgow Coma Scale rating of > 14
- TICH confirmed (group A) or ruled out (group B) by CT, performed within the latest 12 hours.
- Patient ≥ 18 years of age.
- Patient has signed the Informed Consent Form.
Who cannot join
- Patient has confirmed or suspected skull fracture.
- Patient has confirmed or suspected cervical spine fracture.
- The diagnostic procedure is deemed to interfere with the standard of care.
- Patient has a shunt or other foreign object implanted intracranially.
- Patient has agraffes/other metal parts, thick (> 1 cm) bandage, or other foreign materials attached to the head that are deemed to interfere with the diagnostic procedure.
- Any other condition or symptoms preventing the patient from entering the study, according to the Investigator's judgment.
- Females who are pregnant.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Sahlgrenska University Hospital, Department of Surgery, Trauma Unit
Gothenburg, Västra Götaland County, 413 45
About this study
Official title: Detecting Traumatic Intracranial Hemorrhage With Microwave Technology - An Open Study Evaluating the Diagnostic Accuracy of a Microwave-based Device to Detect Traumatic Intracranial Hemorrhage (TICH), by Comparing Measurements on Trauma Patients With Confirmed vs Excluded TICH
An open study evaluating the diagnostic accuracy of a microwave-based device to detect traumatic intracranial hemorrhage (TICH), by comparing measurements on trauma patients with confirmed vs excluded TICH
Read the detailed description
This open study will enrol trauma patients admitted to the Trauma Unit, Department of Surgery at Sahlgrenska University Hospital/Sahlgrenska. It will compare patients where TICH has been confirmed by CT (group A) to patients where CT has ruled out TICH (group B). Patients will be asked to participate in the study as early as possible after admission and CT scan. After physical examination, checking inclusion/exclusion criteria, and after informed consent has been acquired, the baseline microwave-based measurement will be performed. The diagnostic procedure is estimated to take 15 min; whereof total subject measurement time will be less than five minutes. Follow-up microwave measurements will be performed in conjunction with any follow-up CTs performed as part of the standard of care, during the hospitalized treatment period. If no follow-up CTs are performed as part of the standard of care, only the baseline microwave measurement will be performed.
Safety will be followed throughout the study, and a safety follow-up will be performed 12 hours after the last microwave-based investigation is finalized.
- Conditions
- Traumatic Intracranial Hemorrhage
- Being tested
- Medfield Strokefinder MD100
- Medical subject headings
- Intracranial Hemorrhage, Traumatic
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.
The diagnostic ability as measured by the area under receiver operating characteristic curve (AUC) of the device for detecting TICH
The diagnostic ability of the device is calculated using a leave-one-out/n-fold cross-validation method
Measured: The diagnostic procedure has an estimated duration of 15 minutes
Secondary outcomes (4)
The accuracy for estimating the position of the intracranial hemorrhage through a mathematical analysis of the microwave data
Measured: The diagnostic procedure has an estimated duration of 15 minutes
The accuracy for estimating the volume of the intracranial hemorrhage through a mathematical analysis of the microwave data
Measured: The diagnostic procedure has an estimated duration of 15 minutes
Mean time (± standard deviation) needed to complete the measurement procedure
Measured: The diagnostic procedure has an estimated duration of 15 minutes
Any adverse events occurring within 12 hours from the measurement procedure(s)
Measured: The diagnostic procedure has an estimated duration of 15 minutes, a safety follow-up will be performed 12 hours after the diagnostic procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2016 (estimated)
- Study startApr 2016
- Primary completion1 Nov 2019
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Intracranial HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hans Granhed
- Sponsor type
- University, hospital or other
- Collaborators
- Medfield Diagnostics, Chalmers University of Technology
- Responsible party
- Sponsor-investigator, Hans Granhed, Sahlgrenska University Hospital
- Investigators
- Hans Granhed, MD, PhD, Principal investigator, Sahlgrenska University Hospital, Department of Surgery, Trauma Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02728908
- Sponsor's protocol ID
- TICH 01
- Status last verified
- Jan 2020
- First submitted
- 31 Mar 2016
- Last updated
- 31 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detecting Traumatic Intracranial Hemorrhage With Microwave Technology - An Open Study Evaluating the Diagnostic Accuracy of a Microwave-based Device to Detect Traumatic Intracranial Hemorrhage (TICH), by Comparing Measurements on Trauma Patients With Confirmed vs Excluded TICH
- ClinicalTrials.gov ID
- NCT02728908
- Acronym / sponsor ID
- TICH 01
- Conditions
- Traumatic Intracranial Hemorrhage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Hans GranhedUniversity, hospital or other
- Collaborators
- Medfield Diagnostics, Chalmers University of Technology
- Study start
- Apr 2016
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 5 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An open study evaluating the diagnostic accuracy of a microwave-based device to detect traumatic intracranial hemorrhage (TICH), by comparing measurements on trauma patients with confirmed vs excluded TICH
Detailed description
This open study will enrol trauma patients admitted to the Trauma Unit, Department of Surgery at Sahlgrenska University Hospital/Sahlgrenska. It will compare patients where TICH has been confirmed by CT (group A) to patients where CT has ruled out TICH (group B). Patients will be asked to participate in the study as early as possible after admission and CT scan. After physical examination, checking inclusion/exclusion criteria, and after informed consent has been acquired, the baseline microwave-based measurement will be performed. The diagnostic procedure is estimated to take 15 min; whereof total subject measurement time will be less than five minutes. Follow-up microwave measurements will be performed in conjunction with any follow-up CTs performed as part of the standard of care, during the hospitalized treatment period. If no follow-up CTs are performed as part of the standard of care, only the baseline microwave measurement will be performed.
Safety will be followed throughout the study, and a safety follow-up will be performed 12 hours after the last microwave-based investigation is finalized.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient admitted to Sahlgrenska University Hospital for trauma care.
- Patient deemed clinically stable.
- Patient should have a Glasgow Coma Scale rating of > 14
- TICH confirmed (group A) or ruled out (group B) by CT, performed within the latest 12 hours.
- Patient ≥ 18 years of age.
Key exclusion criteria (7 listed)
- Patient has confirmed or suspected skull fracture.
- Patient has confirmed or suspected cervical spine fracture.
- The diagnostic procedure is deemed to interfere with the standard of care.
- Patient has a shunt or other foreign object implanted intracranially.
- Patient has agraffes/other metal parts, thick (> 1 cm) bandage, or other foreign materials attached to the head that are deemed to interfere with the diagnostic procedure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medfield Strokefinder MD100Measurement with Medfield Strokefinder MD100 | Device | – |
Primary outcome
The diagnostic ability as measured by the area under receiver operating characteristic curve (AUC) of the device for detecting TICH
Time frame: The diagnostic procedure has an estimated duration of 15 minutes
The diagnostic ability of the device is calculated using a leave-one-out/n-fold cross-validation method
4 secondary outcomes
The accuracy for estimating the position of the intracranial hemorrhage through a mathematical analysis of the microwave data
Time frame: The diagnostic procedure has an estimated duration of 15 minutes
The accuracy for estimating the volume of the intracranial hemorrhage through a mathematical analysis of the microwave data
Time frame: The diagnostic procedure has an estimated duration of 15 minutes
Mean time (± standard deviation) needed to complete the measurement procedure
Time frame: The diagnostic procedure has an estimated duration of 15 minutes
Any adverse events occurring within 12 hours from the measurement procedure(s)
Time frame: The diagnostic procedure has an estimated duration of 15 minutes, a safety follow-up will be performed 12 hours after the diagnostic procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans Granhed, MD, PhD principal investigator
Sahlgrenska University Hospital, Department of Surgery, Trauma Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medfield Strokefinder MD100 in people with Traumatic Intracranial Hemorrhage, run by Hans Granhed 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 6 inclusion and 7 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 31 Jan 2020. 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?
The diagnostic ability as measured by the area under receiver operating characteristic curve (AUC) of the device for detecting TICH (time frame: The diagnostic procedure has an estimated duration of 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jan 2020.