Clinical trials: Cranioplasty, active
Cranioplasty, Craniofacial Abnormalities
Stryker PEEK Customized Implant: A Prospective Post Market Follow Up to Evaluate Safety, Performance and Effectiveness
The purpose of this study is to confirm the safety, performance and effectiveness of Stryker's PEEK Customized Implants when used for the augmentation and/or restoration of bony and/or soft tissue deformities in the cranial and…
- Conditions
- Cranioplasty, Craniofacial Abnormalities, Craniofacial Injuries
- Trial name
- NCT05362370
- Testing
- Stryker's PEEK Customized Implant
- Where
- 13 sites in United States, Austria and 4 more
- Volunteers
- 99 people
- Sponsor
- Stryker Craniomaxillofacial
Cranial Defect
Study on the Effect of Ultra-early Autologous Cranioplasty on Neurological Function Recovery
To compare the neurological recovery and complication rate of autogenous cranioplasty(CP) within 6 weeks after decompressive craniectomy (DC) with that of autogenous cranioplasty within 3~6 months after DC.
- Trial name
- FAST-ECP (NCT07183540)
- Testing
- operation opportunity-within 6 weeks after the DC operation., operation opportunity-within 90 to 180 days after the DC operation.
- Where
- 7 sites in China
- Volunteers
- 582 people
- Sponsor
- The Affiliated Hospital Of Guizhou Medical University
Brain Injury, Neuropsychological Deficits
Cognitive Functions in Severe Acquired Brain Injury After Cranioplasty
Cranioplasty is the main reconstructive neurosurgical procedure, performed in approximately 80% of patients who have previously undergone demolitive surgeries in an emergency setting, particularly in the case of decompressive…
- Conditions
- Brain Injury, Neuropsychological Deficits, Cranioplasty, Cognitive Deficit Following Brain Lesions
- Trial name
- NeC (NCT06895109)
- Testing
- improvement of cognitive functions and psychological aspects
- Where
- Italy
- Volunteers
- 20 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Cranioplasty, Sonolucent Cranioplasty
Transcranial Ultrasound Via Sonolucent Cranioplasty
Transcranial Ultrasound via Sonolucent Cranioplasty is a prospective, single arm, observational, open label (non-blinded) study to collect real world evidence on the use of transcranial ultrasound via sonolucent cranioplasty.
- Conditions
- Cranioplasty, Sonolucent Cranioplasty, Reconstructive Cranioplasty
- Trial name
- NCT06097845
- Testing
- Transcranial Ultrasound
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Northwell Health
Craniocerebral Trauma, Stroke
Timing Impact of Early vs. Late Cranioplasty on Hemicraniectomy Outcomes
This prospective, randomized study aims to comprehensively evaluate the impact of cranioplasty timing on postoperative complications and long-term functional outcomes following decompressive hemicraniectomy (DHC).
- Conditions
- Craniocerebral Trauma, Stroke, Intracranial Hemorrhages
- Trial name
- TIMELY (NCT06632587)
- Testing
- Early cranioplasty, Standard-of-care cranioplasty
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Thomas Jefferson University
Skull Defect
Prospective Observational Study on Comprehensive Effects of PEEK Cranioplasty and Titanium Cranioplasty After DC（RECEPT-DC）
The objective of this trial is to scientifically evaluate the efficacy of PEEK cranioplasty and titanium cranioplasty. The primary objective is to compare the rate of implant failure (defined as infection, implant exposure and…
- Trial name
- NCT05416684
- Where
- China
- Volunteers
- 358 people
- Sponsor
- RenJi Hospital
Ventriculoperitoneal Shunt (VPS), Cranioplasty
Simultaneous Vs Staged VPS and CP :A Multi-cnter RCT.
The purpose of this prospective, multi-center randomized controlled trail is to compare the safety and efficacy of sequential surgery or staged surgery in patients with skull defect and hydrocephalus.
- Trial name
- NCT07462676
- Testing
- Time of choosing VPS and VP
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Anhui Provincial Hospital
Cranioplasty, Craniotomy
Effectiveness of 3D Bone Matrix in Cranioplasty
The objective of this clinical trial is to evaluate the effectiveness of a 3D bone scaffold in relation to a scaffold formed by PCL + β-TCP (polycaprolactone and beta-tricalcium phosphate), compared to the use of PMMA (polymethyl…
- Conditions
- Cranioplasty, Craniotomy, Craniotomy Clipping, Craniotomy Surgery
- Trial name
- OSTEOPRINTCR (NCT06792864)
- Testing
- OsteoprintCR, SMAR SET GMV Endurance Gentamicin
- Where
- Chile
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Universidad Austral de Chile
Stroke
A Space-expanding Shield in Decompressive Hemicraniectomy for Stroke
Instead of the standard decompressive hemicraniectomy with subsequent cranioplasty a single surgery with the implantation of an individually molded space-expanding shield is investigated in for patients with increased…
- Trial name
- SPACE SHIELD (NCT06638385)
- Testing
- DCE + SPACE SHIELD, DCE + CP
- Where
- 6 sites in Switzerland
- Volunteers
- 110 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Clinical Need for Craniotomy or Craniectomy, Clinical Need for Cranioplasty
A Multi-center, Early Feasibility Study of Using the Mechanical Tissue Resuscitation™ (MTR®) Therapy System for Removal of Excess Fluid in Subjects Who Have Had a Portion of Their Skull Removed to Expose the Dura/Brain and Require Drainage for Fluid Removal.
A multi-center, early feasibility study of using the Mechanical Tissue Resuscitation™ (MTR®) therapy system for removal of excess fluid in subjects who have had a portion of their skull removed to expose the dura/brain and…
- Trial name
- NCT06201429
- Testing
- Mechanical Tissue Resuscitation™ (MTR®)
- Where
- 3 sites in United States
- Volunteers
- 11 people
- Sponsor
- Renovo Concepts, Inc.
Skull Defect
3D Printed PEEK Implants for Cranioplasty
This study is a non-randomised and single center study with patients needing an artificial skull bone eg cranioplasty. 40 patients will be implanted with in house manufactured polyether ether ketone (PEEK) implants using a fused…
- Trial name
- PEEKCP (NCT05291754)
- Testing
- PEEK Cranioplasty
- Where
- Sweden
- Volunteers
- 40 people
- Sponsor
- Skane University Hospital
Cranial Defects
Efficacy and Safety of 3D-Printed PEEK Skull Implants in Cranioplasty
The goal of this clinical trial is to determine the efficacy and safety of customized skull implants made of polyetheretheretherketone by three-dimensional printing in patients undergoing cranioplasty.
- Trial name
- NCT06782711
- Testing
- cranioplasty, customized skull implants made of polyetheretheretherketone (PEEK) using 3D printing
- Where
- Mexico
- Volunteers
- 30 people
- Sponsor
- CIMET SCIENTIFIC CORPORATION
Transcranial Ultrasound With Sonolucent Cranioplasty, TUSC
Transcranial Ultrasound Via Sonolucent Cranioplasty After Minimally Invasive Intracerebral Hemorrhage Evacuation
Postoperative rebleeding is a major limitation of surgical evacuation for intracerebral hemorrhage (ICH). While computed tomography (CT) is the standard of care for postoperative hematoma cavity monitoring, CT requires…
- Trial name
- TUSC MIS (NCT05538286)
- Testing
- ClearFit implant, transcranial ultrasonography through sonolucent cranioplasty
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Cranial Bone, Post-operative Complications
Evaluation of Cranial Flap Fixation With Montage Flowable Settable Bone Paste
Montage Flowable Settable Bone Paste is a self-setting calcium phosphate cement indicated for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects with a surface area no larger than…
- Conditions
- Cranial Bone, Post-operative Complications, Cranial Fixation, Cranioplasty
- Trial name
- NCT07103330
- Testing
- Metallic fixation hardware, Cranial flap placement and fixation using only Montage Flowable Settable Bone Paste
- Volunteers
- 100 people
- Sponsor
- Abyrx, Inc.