Clinical trials: Craniotomy
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
Chronic Subdural Hematoma, cSDH
Prospective Multi-center Single Arm Study for Subjects With Chronic Subdural Hematoma Treated With i-ED COILs, Either Alone or in Combination With Burr-holes or Mini-craniotomy
All participants will be asked to have a minimally invasive procedure for the treatment of chronic subdural hematoma, a blood clot on the brain.
- Conditions
- Chronic Subdural Hematoma, cSDH, Chronic Subdural Hematomas
- Trial name
- iCURE cSDH (NCT07214623)
- Testing
- Neuro endovascular embolic coil
- Where
- 2 sites in United States
- Volunteers
- 200 people
- Sponsor
- Kaneka Medical America LLC
Malignant Glioma, Glioblastoma Multiforme
Interstitial Infusion of IL13-PE38QQR Cytotoxin in Recurrent Malignant Glioma
IL13-PE38QQR is an oncology drug product consisting of IL13 (interleukin-13) and PE38QQR (a bacteria toxin). IL3-PE38QQR is a protein that exhibits cell killing activity against a variety of IL13 receptor-positive tumor cell…
- Conditions
- Malignant Glioma, Glioblastoma Multiforme, Anaplastic Astrocytoma, Mixed Oligoastrocytoma
- Trial name
- NCT00024570
- Testing
- IL13-PE38QQR, targeted fusion protein therapy, surgery
- Where
- 8 sites in United States
- Volunteers
- 60 people
- Sponsor
- INSYS Therapeutics Inc
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
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.
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
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
Cerebrospinal Fluid Leakage
Performance and Safety of I-020805 in Prevention of Cerebrospinal Fluid (CSF) Leakage Following Elective Craniotomy
This is a prospective study to evaluate the performance and safety of a new medical device used in case of cerebrospinal fluid (CSF) leakage after an elective cranial surgery.
- Trial name
- NCT01295619
- Testing
- I-020805
- Where
- 4 sites in Germany, Hungary
- Volunteers
- 41 people
- Sponsor
- Kuros Biosurgery AG
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
Brain Edema, TBI (Traumatic Brain Injury)
Dynamic Decompressive Craniotomy
Prospective observational study on patients undergoing decompressive craniotomy
- Conditions
- Brain Edema, TBI (Traumatic Brain Injury), Stroke, Acute, Cerebral Hemorrhage
- Trial name
- NCT05051488
- Testing
- Dynamic craniotomy
- Volunteers
- 20 people
- Sponsor
- Rohit Khanna, MD
Recurrent Malignant Glioma
Phase I/II Trial of Intracerebral IL13-PE38QQR Infusions in Pediatric Patients With Recurrent Malignant Glioma
IL13-PE38QQR is an oncology drug product consisting of IL13 (interleukin-13) and PE38QQR (a bacteria toxin). IL3-PE38QQR is a protein that exhibits cell killing activity against a variety of IL13-receptor positive tumor cell…
- Trial name
- NCT00378235
- Testing
- IL13-PE38QQR
- Where
- 10 sites in United States
- Sponsor
- INSYS Therapeutics Inc
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.
Malignant Glioma, Glioblastoma Multiforme
Histologic Effect/Safety of Pre/Post-Operative IL13-PE38QQR in Recurrent Resectable Supratentorial Malignant Glioma Patients
IL13-PE38QQR is an oncology drug product consisting of IL13 (interleukin-13) and PE38QQR (a bacteria toxin). IL3-PE38QQR is a protein that exhibits cell killing activity against a variety of IL13 receptor-positive tumor cell…
- Conditions
- Malignant Glioma, Glioblastoma Multiforme, Anaplastic Astrocytoma, Mixed Oligoastrocytoma
- Trial name
- NCT00024557
- Testing
- IL13-PE38QQR, targeted fusion protein therapy, surgery
- Where
- 4 sites in United States
- Volunteers
- 40 people
- Sponsor
- INSYS Therapeutics Inc
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
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
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 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.
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
Astrocytoma, Brain Cancer
Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of QBS10072S
This is a multi-center, open-label, dose escalation study to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and maximum tolerated dose (MTD) of QBS10072S in patients with advanced or metastatic cancers…
- Conditions
- Astrocytoma, Brain Cancer, Brain Metastases, Bladder Cancer
- Trial name
- NCT04430842
- Testing
- QBS10072S
- Where
- 2 sites in Australia
- Volunteers
- 15 people
- Sponsor
- Quadriga Biosciences, Inc.