NCT07122752Active, not recruiting
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
Source: ClinicalTrials.gov · Last updated 8 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 32 (actual)
- First submitted
- 31 Jul 2025
- Start date
- 29 Jul 2025
- Primary completion date
- 29 Aug 2027
- Lead sponsor
- Tan Tock Seng Hospital
- Diseases
- Stroke
- NCT number
- NCT07122752
What you commit to
- Study type: Observational
- Participants enrolled: 32
- From 29 Jul 2025 to the primary completion date, 29 Aug 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Known allergy to investigational products
Other illness
- Uncontrolled medical illnesses, e.g. sepsis, delirium, active malignancy
- Unhealed or infected post-DC neurosurgical wounds
Other
- Vegetative or minimally responsive state
- Life expectancy \< 6 months
Who the study is looking for
- Unilateral decompressive craniectomy (DC)
- Acute Stroke or traumatic brain injury
- \>30 days post DC
- Healed surgical wounds, non-bulging flaps
- Presence of caregiver supervision
Age in the registry: 21 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tan Tock Seng Hospital Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
Related publications
- Preliminary Feasibility Implementation of Post-Decompressive Craniectomy 3D-Printed Externally Applied Cranial Orthosis (PEACO) During Inpatient Rehabilitation: A Retrospective Cohort Study Reporting Short-Term Tolerability and Patient/Caregiver-Reported Feedback.Healthcare (Basel) · 2026 · PMID 42940406
This page is information, not medical advice. Discuss any trial with your doctor.