NCT05226741

Brief Summary

To design and create wearable head protection to be worn on a patient's head following a neurosurgical procedure (namely craniectomy and craniotomy

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 11, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2022

Completed
25 days until next milestone

First Posted

Study publicly available on registry

February 7, 2022

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

February 7, 2022

Status Verified

February 1, 2022

Enrollment Period

4 months

First QC Date

January 13, 2022

Last Update Submit

February 3, 2022

Conditions

Craniectomy

Keywords

helmet, protection,

Outcome Measures

Primary Outcomes (1)

  • Patient Satisfaction Survey

    A survey to assess Satisfaction with device

    6 weeks after receiving their head protection fitting

Secondary Outcomes (1)

  • Euro Quality of Life - 5 Dimensions (EQ-5D)

    6 weeks after receiving their head protection fitting

Study Arms (1)

Head protection

EXPERIMENTAL

Participants are given a form of head protection

Device: Head protection device

Interventions

Head protection deviceDEVICE

The participants are fitted with a form of head protection over the craniectomy and provide feedback on design, use, and comfort

Head protection

Eligibility Criteria

Age21 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects are eligible if they are 21 years or above and have had a DC \>30 days, no wounds, able to understand simple commands and have a primary caregiver

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tan Tock Seng Hospital

Singapore, 308433, Singapore

Location

Related Publications (2)

  • Colasante C, Sanford Z, Castro N, Bartels MN. Custom Fabrication of a 3-Dimensionally Printed Helmet for Improved Socialization and Subjective Self-Assessment in a Case of Acquired Cranial Defect: A Case Presentation. PM R. 2018 Jun;10(6):671-674. doi: 10.1016/j.pmrj.2017.11.005. Epub 2017 Dec 30.

    PMID: 29291381BACKGROUND

  • Lucano LRG, Brambila FJP, Perez JE, Rosales PH. Customized Low-Cost 3D Printed Helmet as a Temporary Measure for a Patient with Acrania. Indian J Plast Surg. 2019 May;52(2):252-253. doi: 10.1055/s-0039-1696077. Epub 2019 Sep 12. No abstract available.

    PMID: 31602146BACKGROUND

Study Officials

  • Trevor Binedell

    Tan Tock Seng Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2022

First Posted

February 7, 2022

Study Start

November 11, 2021

Primary Completion

March 1, 2022

Study Completion

March 1, 2022

Last Updated

February 7, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Anonymised Information will be published in a journal once completed

Locations

SG(1)