Detecting Traumatic Intracranial Hemorrhage With Microwav... | NCT02728908

Studies
Detecting Traumatic Intracranial Hemorrhage With Microwave Technology

NCT02728908

Sponsor

Hans Granhed

Status

Completed

Last Update Posted

Jan 31, 2020Actual

Enrollment

250Actual

Phase

Not Applicable

Conditions

Traumatic Intracranial Hemorrhage

Interventions

Medfield Strokefinder MD100

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2016

Primary Completion Date

Nov 1, 2019Actual

Completion Date

Nov 1, 2019Actual

First Submitted Date

Mar 31, 2016

First Submission Date that Met QC Criteria

Mar 31, 2016

First Posted Date

Apr 5, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 29, 2020

Last Update Posted Date

Jan 31, 2020Actual

Name	Class
Medfield Diagnostics	INDUSTRY
Chalmers University of Technology	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

250Actual

Name	Type	Description	Arm Group Labels	Other Names
Medfield Strokefinder MD100	Device	Measurement with Medfield Strokefinder MD100

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hans Granhed, MD, PhD	Sahlgrenska University Hospital, Department of Surgery, Trauma Unit	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sahlgrenska University Hospital, Department of Surgery, Trauma Unit		Gothenburg	Västra Götaland County	413 45	Sweden

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020198	Intracranial Hemorrhage, Traumatic

Ancestor Terms

ID	Term
D020300	Intracranial Hemorrhages
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided