Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 1:18 PM
Ignite Modification Date:
2025-12-24 @ 1:18 PM
NCT ID:
NCT04021095
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:
NCT04021095
Study Brief:
Protocol Section:
NCT04021095