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Active, Not Recruiting

NCT Number: NCT07122752

Feasibility and Outcomes of 3D-printed External Cranial Orthosis After Craniectomy

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Traumatic Brain Injury Acquired Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Brain Neoplasms Brain Tumor Cardiovascular Diseases Central Nervous System Diseases Central Nervous System Neoplasms Cerebrovascular Disorders Craniocerebral Trauma Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Stroke Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tan Tock Seng Hospital

Singapore

About this study

The study aims to:

  • Evaluate the feasibility, safety and clinical outcomes of a 3D-printed externally applied cranial orthosis (PEACO) in a clinical setting (unmonitored protocol)
  • Comparison of device A - 2021 Head Protection Prototype Device (HPPD) (DSRB 2019/00155)-monitored protocol with device B (PEACO).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Unilateral decompressive craniectomy (DC)
  • Acute Stroke or traumatic brain injury
  • >30 days post DC
  • Healed surgical wounds, non-bulging flaps
  • Presence of caregiver supervision

Exclusion criteria

  • Vegetative or minimally responsive state
  • Uncontrolled medical illnesses, e.g. sepsis, delirium, active malignancy
  • Life expectancy < 6 months
  • Unhealed or infected post-DC neurosurgical wounds
  • Known allergy to investigational products

Treatment and study plan

Primary outcomes

  1. Treatment-emergent adverse events (safety and tolerability)

    Time frame: 30 minutes post fitting (version 1 and 2)

    The therapist will assess patient in terms of pain, redness, skin imprints and pruritus' on patient's skin after wearing the cranial cap. This is to allow the understanding of the incidence of the treatment-emergent adverse events (safety and tolerability).

  2. Patient Reported Outcome Measures (PROMS) PROMs (compliance)

    Time frame: 2023-2025

    The patient will be sent a questionnaire. The question relating to compliance is "Approximately, how many hours of wear per day including rest breaks?" This will allow team to assess feasibility, safety and clinical outcomes.

  3. Patient Reported Outcome Measures (PROMS) PROMs (wearing time)

    Time frame: 2023-2025

    The patient will be sent a questionnaire. The question relating to wearing time is "Approximately, how many hours of wear per day including rest breaks?" This will allow team to assess feasibility, safety and clinical outcomes.

  4. Patient Reported Outcome Measures (PROMS) PROMs (adverse events)

    Time frame: 2023-2025

    The patient will be sent a questionnaire. The question relating to adverse event is "Did you experience any of the following after two hours of wear? This will allow team to assess feasibility, safety and clinical outcomes.

  5. Patient Reported Outcome Measures (PROMS) PROMs (cosmesis rating)

    Time frame: 2023-2025

    The patient will be sent a questionnaire. The question relating to cosmesis rating is "Please rate the appearance of your cranial cap". This will allow team to assess feasibility, safety and clinical outcomes.

Sponsors and collaborators

Lead sponsor

Tan Tock Seng Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 14, 2025
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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