Ignite Creation Date:
2025-12-24 @ 1:18 PM
Ignite Modification Date:
2025-12-24 @ 1:18 PM
Study NCT ID:
NCT04021095
Status:
COMPLETED
Last Update Posted:
2021-04-01
First Post:
2019-07-11
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Novel Head Protection Prototype Device for Decompression Craniectomy
Sponsor:
Tan Tock Seng Hospital
Organization:
Study Overview
Official Title:
An Exploratory Study on the Development of a Novel Head Protection Prototype Device for Post-decompression Craniectomy Patients
Status:
COMPLETED
Status Verified Date:
2019-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HPPD
Brief 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.
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:
1. test the feasibility and safety of customised 3D printed HPPD,
2. integrate the prostheses to the skull defect in removable manner and discharge patient with appropriate education,
3. 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 Specific Objectives:
(i) Primary Objectives
These are to:
1. test the feasibility and safety of customised 3D printed HPPD,
2. integrate the prostheses to the skull defect in removable manner and discharge patient with appropriate education,
3. 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: