Trials / Active Not Recruiting
Active Not RecruitingNCT07122752
Feasibility and Outcomes of 3D-printed External Cranial Orthosis After Craniectomy
Feasibility, Safety and Patient Reported Outcomes of 3D-Printed Externally-applied Cranial Orthosis (PEACO) After Decompression Craniectomy in Clinical Settings: A Retrospective Comparison Study of Monitored Versus Unmonitored Protocols
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 32 (actual)
- Sponsor
- Tan Tock Seng Hospital · Academic / Other
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
Summary
This study will compare the outcomes of a current clinical implementation of PEACO designed for one-handed donning and doffing with carer-monitoring with a previous prototype (HPPD) requiring carer-donning and doffing with therapist monitoring.
Detailed description
The study aims to: 1. Evaluate the feasibility, safety and clinical outcomes of a 3D-printed externally applied cranial orthosis (PEACO) in a clinical setting (unmonitored protocol) 2. Comparison of device A - 2021 Head Protection Prototype Device (HPPD) (DSRB 2019/00155)-monitored protocol with device B (PEACO).
Conditions
Timeline
- Start date
- 2025-07-29
- Primary completion
- 2026-08-29
- Completion
- 2026-08-29
- First posted
- 2025-08-14
- Last updated
- 2025-08-14
Locations
1 site across 1 country: Singapore
Source: ClinicalTrials.gov record NCT07122752. Inclusion in this directory is not an endorsement.