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Novel Head Protection Prototype Device for Decompression Craniectomy

NCT04021095 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2021-04-01

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Head protection prototype device

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.

Sponsors & Collaborators

  • Creatz3D

    collaborator UNKNOWN

  • Tan Tock Seng Hospital

    lead OTHER

Principal Investigators

  • Khai Pang Leong · Tan Tock Seng Hospital Clinical research and innovation office

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-04
Primary Completion
2021-03-31
Completion
2021-03-31

Countries

  • Singapore

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04021095 on ClinicalTrials.gov