Brain InjuriesHPPDNCT04021095
Novel Head Protection Prototype Device for Decompression Craniectomy
A study testing Head protection prototype device in people with Brain Injuries and Stroke, run by Tan Tock Seng Hospital at 1 site in Singapore.
Trial summary
A proof-of-concept (POC) proposal to study the feasibility of customized head protection prototype device (HPPD) using 3D printed externally-applied moulded skin prosthesis integrated to the craniectomy bony skull defect. Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Injuries, Stroke
- What is being tested?
- Head protection prototype device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSingapore
- Study dates
- 4 Jul 2019to 31 Mar 2021
- 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 21 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All subjects must meet all of the inclusion criteria to participate in this study.
- Age 21 to 80 years, both males and females.
- 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.
- Stroke, SAH or TBI are diagnosed by specialists and confirmed on brain imaging studies (CT, MRI)
- Duration from event > 30 days and either during inpatient or outpatient phase.
- Presence of at least 1 post decompressive craniectomy CT brain film performed at NNI/TTSH.
- Healed craniectomy surgical wound without bulging skin flap or active skin infection.
- 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
Who cannot join
- Patient in vegetative or minimally responsive state.
- Presence of uncontrolled medical condition (uncontrolled hypertension, Diabetes Mellitus, sepsis or delirium, active malignancy either cranial or extracranial sites)
- Presence of end organ failure (end stage renal or liver failure, renal dialysis, life expectancy <6 months)
- Presence of pregnancy or lactation.
- Presence of severe agitation /behavioural/active depression or anxiety/ drug or alcohol addiction which would negatively affect compliance,
- Presence of unhealed head wound, active wound infection, scalp dermatitis, wound breakdown which would be worsened by pressure from the HPPD.
Show all 9Show fewer
- Presence of known allergy to the investigational products which is the 3D printed material (e.g. Nylon).
- Subjects' CT brain imaging films are not available to the study team.
- Absence of NOK who can assist monitoring unless subjects is able to self-monitor
Trial locations and contacts
1 site in 1 country.
Singapore1 site
Tan Tock Seng Hospital Rehabilitation Centre
Singapore, 569766
About this study
Official title: An Exploratory Study on the Development of a Novel Head Protection Prototype Device for Post-decompression Craniectomy Patients
A proof-of-concept (POC) proposal to study the feasibility of customized head protection prototype device (HPPD) using 3D printed externally-applied moulded skin prosthesis integrated to the craniectomy bony skull defect.
Read the detailed description
A proof-of-concept (POC) proposal to study the feasibility of customized head protection prototype device (HPPD) using 3D printed externally-applied moulded skin prosthesis integrated to the craniectomy bony skull defect. The proposed material is a bio-compatible, light-weight rigid /semi rigid material which can be fitted to the skull defect and interfaced with the subject's bony rim using soft, deformable material (e.g. silicon) and attached using an elastic head band or other acceptable means. The prosthesis is removable for skin and prosthesis cleansing and ventilation.
Study Specific Objectives:
(i) Primary Objectives
These are to:
- test the feasibility and safety of customised 3D printed HPPD,
- integrate the prostheses to the skull defect in removable manner and discharge patient with appropriate education,
- to systematically monitor subjects for symptoms, compliance, complications and subjective feedback during the outpatient phase where progressive wear of HPPD and monitoring of acceptability will be monitored.
- Conditions
- Brain Injuries, Stroke
- Being tested
- Head protection prototype device
- Medical subject headings
- Brain Injuries, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Head protection prototype deviceDevice
The proposed experimental HPPD uses biocompatible material using FDMÔNylon which has high fatigue resistance, chemical resistance with impact resistance and toughness which is free of powders. It is HSA unclassified as yet and the FDMONylon is not FDA approved yet.
| Study group | Role | What they receive |
|---|---|---|
| Decompressive craniectomy | Experimental | 3D printed skull replacement piece will be fitted to subject. Receives: Device: Head protection prototype device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of acute complications at second hour of HPPD fitting
Complications are defined as immediate complaints of pain or discomfort and /or signs of bony defect scar pressure redness or wound breakdown within the first 2 hours in the research clinic.
Measured: 12 months
Secondary outcomes (1)
Percentage of acute complications at end of first week of HPPD use.
Complications are defined as pain or discomfort or signs of bony defect scar pressure or redness or wound breakdown in the first week post-fitting of HPPD
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start4 Jul 2019
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuriesStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Customised head protection prototype device.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tan Tock Seng Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Creatz3D
- Responsible party
- Sponsor
- Investigators
- Khai Pang Leong, Study director, Tan Tock Seng Hospital Clinical research and innovation office
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04021095
- Sponsor's protocol ID
- DSRB2019/00155
- Acronym
- HPPD
- Status last verified
- Nov 2019
- First submitted
- 11 Jul 2019
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the visual nature of the study data (digital photo facial images), only study team researchers will have access to identifiable participant data and images.
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study on the Development of a Novel Head Protection Prototype Device for Post-decompression Craniectomy Patients
- ClinicalTrials.gov ID
- NCT04021095
- Acronym / sponsor ID
- HPPD / DSRB2019/00155
- Conditions
- Brain Injuries, Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Tan Tock Seng HospitalUniversity, hospital or other
- Collaborators
- Creatz3D
- Study start
- 4 Jul 2019 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 16 Jul 2019 (actual)
- 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.
A proof-of-concept (POC) proposal to study the feasibility of customized head protection prototype device (HPPD) using 3D printed externally-applied moulded skin prosthesis integrated to the craniectomy bony skull defect.
Detailed description
A proof-of-concept (POC) proposal to study the feasibility of customized head protection prototype device (HPPD) using 3D printed externally-applied moulded skin prosthesis integrated to the craniectomy bony skull defect. The proposed material is a bio-compatible, light-weight rigid /semi rigid material which can be fitted to the skull defect and interfaced with the subject's bony rim using soft, deformable material (e.g. silicon) and attached using an elastic head band or other acceptable means. The prosthesis is removable for skin and prosthesis cleansing and ventilation.
Study Specific Objectives:
(i) Primary Objectives
These are to:
- test the feasibility and safety of customised 3D printed HPPD,
- integrate the prostheses to the skull defect in removable manner and discharge patient with appropriate education,
- to systematically monitor subjects for symptoms, compliance, complications and subjective feedback during the outpatient phase where progressive wear of HPPD and monitoring of acceptability will be monitored.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Customised head protection prototype device.
| Arm | Type | Receives |
|---|---|---|
| Decompressive craniectomy | Experimental | Device: Head protection prototype device3D printed skull replacement piece will be fitted to subject. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- All subjects must meet all of the inclusion criteria to participate in this study.
- Age 21 to 80 years, both males and females.
- 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.
- Stroke, SAH or TBI are diagnosed by specialists and confirmed on brain imaging studies (CT, MRI)
- Duration from event > 30 days and either during inpatient or outpatient phase.
Key exclusion criteria (9 listed)
- Patient in vegetative or minimally responsive state.
- Presence of uncontrolled medical condition (uncontrolled hypertension, Diabetes Mellitus, sepsis or delirium, active malignancy either cranial or extracranial sites)
- Presence of end organ failure (end stage renal or liver failure, renal dialysis, life expectancy <6 months)
- Presence of pregnancy or lactation.
- Presence of severe agitation /behavioural/active depression or anxiety/ drug or alcohol addiction which would negatively affect compliance,
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 |
|---|---|---|
| Head protection prototype deviceThe proposed experimental HPPD uses biocompatible material using FDMÔNylon which has high fatigue resistance, chemical resistance with impact resistance and toughness which is free of powders. It is HSA unclassified as yet and the FDMONylon is not FDA approved yet. | Device | Decompressive craniectomy |
Primary outcome
Percentage of acute complications at second hour of HPPD fitting
Time frame: 12 months
Complications are defined as immediate complaints of pain or discomfort and /or signs of bony defect scar pressure redness or wound breakdown within the first 2 hours in the research clinic.
1 secondary outcome
Percentage of acute complications at end of first week of HPPD use.
Time frame: 12 months
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 1 Apr 2021.
- Individual participant dataSharing planned: No. Due to the visual nature of the study data (digital photo facial images), only study team researchers will have access to identifiable participant data and images.
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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.
Khai Pang Leong study director
Tan Tock Seng Hospital Clinical research and innovation office
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Head protection prototype device in people with Brain Injuries and Stroke, run by Tan Tock Seng Hospital at 1 site in Singapore.
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 8 inclusion and 9 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 1 Apr 2021. 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 Singapore. 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?
Percentage of acute complications at second hour of HPPD fitting (time frame: 12 months). 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 1 Apr 2021.