Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:18 PM
Ignite Modification Date:
2025-12-24 @ 1:18 PM
NCT ID:
NCT04021095
Eligibility Criteria:
Inclusion Criteria:
All subjects must meet all of the inclusion criteria to participate in this study.
1. Age 21 to 80 years, both males and females.
2. Presence of surgical unilateral or bilateral craniectomy performed for reasons of ischaemic or haemorrhagic stroke, Subarachnoid haemorrhage (SAH), traumatic brain injury (TBI), benign cerebral tumours, etc.
3. Stroke, SAH or TBI are diagnosed by specialists and confirmed on brain imaging studies (CT, MRI)
4. Duration from event \> 30 days and either during inpatient or outpatient phase.
5. Presence of at least 1 post decompressive craniectomy CT brain film performed at NNI/TTSH.
6. Healed craniectomy surgical wound without bulging skin flap or active skin infection.
7. Patients awaiting elective cranioplasty or those who refuse cranioplasty. 8 Ability to understand simple instructions and give own consent. 9 Presence of family members or NOK who can supervise the patient to don the head protection device, care for the material and regularly monitor for compliance and complications 10 Reproductive age females should not be pregnant at the point of consent-taking and during the study
Exclusion Criteria:
1. Patient in vegetative or minimally responsive state.
2. Presence of uncontrolled medical condition (uncontrolled hypertension, Diabetes Mellitus, sepsis or delirium, active malignancy either cranial or extracranial sites)
3. Presence of end organ failure (end stage renal or liver failure, renal dialysis, life expectancy \<6 months)
4. Presence of pregnancy or lactation.
5. Presence of severe agitation /behavioural/active depression or anxiety/ drug or alcohol addiction which would negatively affect compliance,
6. Presence of unhealed head wound, active wound infection, scalp dermatitis, wound breakdown which would be worsened by pressure from the HPPD.
7. Presence of known allergy to the investigational products which is the 3D printed material (e.g. Nylon).
8. Subjects' CT brain imaging films are not available to the study team.
9. Absence of NOK who can assist monitoring unless subjects is able to self-monitor
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
80 Years
Study:
NCT04021095
Study Brief:
Protocol Section:
NCT04021095