Clinical trials: Craniotomy
Craniotomy
A Pilot Study to Evidence Improved Cranial Flap Fixation With a Bioresorbable Bone Adhesive
This clinical pilot study will evaluate the use of a bioresorbable bone adhesive to improve cranial flap fixation at two study time points (at the time of fixation and 6 months).
- Trial name
- NCT06095531
- Testing
- Tetranite for Cranial Flap Fixation (TN-CFF)
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- RevBio
Neurosurgery, Surgical Planning
Real Time Craniotomy Planning Using Mixed Reality
This study is a prospective observational study designed to evaluate the effectiveness of Brainlab's Mixed Reality Viewer in enhancing the accuracy and efficiency of preoperative craniotomy planning.
- Conditions
- Neurosurgery, Surgical Planning, Brain Tumor Adult, Craniotomy Tumor Removal Surgery
- Trial name
- NCT07468370
- Testing
- Mixed Reality Glasses/Viewer, Survey using a questionnaire.
- Where
- United States
- Volunteers
- 54 people
- Sponsor
- Brainlab AG
Craniotomy
A Registry Study to Assess SYNTHECELTM Dura Repair
The purpose of this study is to assess how safe synthecel dura repair is and how well it performs in participants undergoing cranial surgery requiring dura repair (a procedure to close and protect the outer covering of the brain)…
- Trial name
- NCT07758790
- Volunteers
- 112 people
- Sponsor
- DePuy Synthes Products, Inc.
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.
Meningioma, Tumor, Brain
MiDura-Study (Neuro-Patch in Duraplasty)
The aim of this study is to collect systematically and proactively data regarding the performance of Neuro-Patch, like complications and handling, under daily clinical practice when used as intended by the manufacturer
- Conditions
- Meningioma, Tumor, Brain, Chiari Malformation, Vascular Malformation
- Trial name
- MiDura (NCT04189172)
- Where
- 4 sites in France, Germany
- Volunteers
- 328 people
- Sponsor
- Aesculap AG
Craniotomy
Safety and Effectiveness of TETRANITE Bone Adhesive for Cranial Flap Fixation Compared to Traditional Metal Hardware
The aim of this study is to demonstrate the safety and efficacy of TETRANITE, a bioresorbable bone adhesive, for Cranial Flap Fixation as compared to traditional metal hardware.
- Trial name
- NCT07452549
- Testing
- Tetranite for Cranial Flap Fixation, Standard of Care Plating System
- Volunteers
- 204 people
- Sponsor
- RevBio
Craniotomy
Post Market Study of Tutopatch In Craniotomy
This is a post market prospective, multi-center study of up to 75 participants at approximately 8 clinical study sites. The objective of the study is to evaluate safety by assessing incidence of device and/or procedure related…
- Trial name
- NCT07118020
- Where
- 2 sites in Austria, Spain
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- RTI Surgical
Craniotomy for Epilepsy and Malignant Tumor Removal
Brain-Shift Monitoring Using 3D Scanning
A prospective non-invasive data/image collection for evaluation of the performance of the Advanced Scanners 3D scanner during brain surgery.
- Trial name
- NCT05018338
- Testing
- Brain shift monitoring
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Advanced Scanners Inc.
Craniotomy, Duraplasty
Assessment of the Performance of LYoplant® ONlay for Duraplasty
The aim of this Post Market Clinical Follow-up Study is to collect clinical data on the performance of Lyoplant® Onlay. To assess the performance of the product, various safety and efficacy parameters have been selected.
- Conditions
- Craniotomy, Duraplasty, Spinal Surgery
- Trial name
- LYON (NCT02678156)
- Testing
- Lyoplant Onlay
- Where
- 3 sites in Germany
- Volunteers
- 61 people
- Sponsor
- Aesculap AG
Craniotomy
A Pilot Clinical Study to Evidence Improved Cranial Flap Fixation With a Bioresorbable Bone Adhesive
This clinical pilot study will evaluate the use of a bioresorbable bone adhesive to improve cranial flap fixation at two study time points (at the time of fixation and 6 months).
- Trial name
- NCT06780852
- Testing
- Tetranite for Cranial Flap Fixation (TN-CFF)
- Where
- United Kingdom
- Volunteers
- 15 people
- Sponsor
- RevBio
Craniotomy
Bone Flap Fixation Systems For Craniotomy Procedures
Clinical investigation to compare the clinical safety and performance of a clamp-like device for craniotomy closure, with the standard of care system, titanium plates and screws.
- Trial name
- LOOP2 (NCT04859907)
- Testing
- Clamp-like system, Plates and screws
- Where
- 3 sites in Slovenia, Spain
- Volunteers
- 60 people
- Sponsor
- NEOS Surgery
E04.525.190, Craniotomy
Case Series to Evaluate Patient Specific Implants (PSI) in Polyether Ether Ketone (PEEK) Performance After 2 Years
The primary objective of this retrospective study is to evaluate the percentage of patients with device related adverse events (infection, rejection, dislocation, fracture of the implant) in the first 24 months after implantation.
- Conditions
- E04.525.190, Craniotomy, Craniectomy
- Trial name
- NCT01282645
- Testing
- PSI in PEEK
- Where
- 30 sites in Austria, Belgium and 13 more
- Sponsor
- Synthes GmbH