NCT02728908

Brief 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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2016

Completed
1 day until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 5, 2016

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

January 31, 2020

Status Verified

January 1, 2020

Enrollment Period

3.6 years

First QC Date

March 31, 2016

Last Update Submit

January 29, 2020

Conditions

Traumatic Intracranial Hemorrhage

Outcome Measures

Primary Outcomes (1)

  • 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

    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

    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

    The diagnostic procedure has an estimated duration of 15 minutes

  • Mean time (± standard deviation) needed to complete the measurement procedure

    The diagnostic procedure has an estimated duration of 15 minutes

  • Any adverse events occurring within 12 hours from the measurement procedure(s)

    The diagnostic procedure has an estimated duration of 15 minutes, a safety follow-up will be performed 12 hours after the diagnostic procedure

Interventions

Medfield Strokefinder MD100DEVICE

Measurement with Medfield Strokefinder MD100

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska University Hospital, Department of Surgery, Trauma Unit

Gothenburg, Västra Götaland County, 413 45, Sweden

Location

MeSH Terms

Conditions

Intracranial Hemorrhage, Traumatic

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemVascular DiseasesCardiovascular DiseasesWounds and Injuries

Study Officials

  • Hans Granhed, MD, PhD

    Sahlgrenska University Hospital, Department of Surgery, Trauma Unit

    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
SPONSOR INVESTIGATOR
PI Title
Sponsor-Investigator

Study Record Dates

First Submitted

March 31, 2016

First Posted

April 5, 2016

Study Start

April 1, 2016

Primary Completion

November 1, 2019

Study Completion

November 1, 2019

Last Updated

January 31, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)