Clinical Studies
Conducting research to advance medical technology
Advancing technology for clinicians and patients
Brainlab partners with clinical sites to conduct research with the aim of improving clinical outcomes, increasing patient satisfaction, and reducing hospitals’ costs.
Ways we support clinical studies and research
Clinical research can include any research conducted with human subjects at the clinical site. Scientific research includes animal, cadaveric, algorithm testing, and other research not involving living human subjects. Studies can either be sponsored by Brainlab or initiated by the investigator.
These studies are planned and sponsored by Brainlab with the clinical site conducting the research.
Brainlab roles & responsibilities:
- Provide required Brainlab products and training
- Draft the clinical cooperation agreement, including standard terms & conditions
- Obtain necessary regulatory approval
- Prepare the study protocol
- Assure the validity of the study data
Principle investigator roles & responsibilities:
- Check the data generated during the study
- Conduct the study
- Report safety data to regulatory authorities, IRB/EC and Brainlab
- Joint submission to the IRB/EC
- Submit study data updates in accordance with the clinical cooperation agreement
Brainlab typically has rights to all intellectual property developed from Brainlab sponsored study data.
Data usageBrainlab manages data and provides guidelines for subject consent.
MonitoringBrainlab is responsible for organizing monitoring.
These are research projects proposed and planned by the clinical site, which takes on the role of study sponsor.
Brainlab roles & responsibilities:
- Provide required Brainlab products and training
- Draft the clinical cooperation agreement, including standard terms & conditions
Principle investigator roles & responsibilities:
- Secure all appropriate regulatory approvals
- Prepare and take ownership of the study protocol
- Assure the validity of the study data
- Conduct the study
- Check the data generated during the study
- Report safety data to regulatory authorities, the IRB/EC, and Brainlab
- Submit study data updates in accordance with the clinical cooperation agreement
- Submit the study results to a peer-reviewed journal for publication
Intellectual property rights are dependent on the specific study protocol and clinical cooperation agreement.
Data usageThe principal investigator manages data and is responsible for subject consent and gives Brainlab rights to use the data, if applicable.
MonitoringPrincipal investigator is responsible for study conduct and data validity.
Support & funding
The types of support we typically provide are the provision of products and/or reimbursement for time spent conducting the study.
Reimbursement
If support is being requested in the form of reimbursement, both Brainlab and the investigator must agree on a budget plan. The budget includes a list of deliverables from both parties and costs must reflect fair market value.
Provision of products
Brainlab may provide support through the provision of products for the duration of the clinical cooperation. If provided, we will offer appropriate training and technical support of those provided products.
Support with study documents
We offer our support with completing study documents, such as EC/IRB approval, manuscripts for publication, study protocols, white papers, case report forms and patient consent, as indicated in the clinical cooperation agreement.
How to start a clinical study
Are you interested in beginning research with Brainlab? Click below to fill out the clinical study request form and we’ll review your proposal.
Clinical Cooperation Process
What happens during the clinical cooperation process?
Clinical Cooperation Process
What happens during the clinical cooperation process?
Become a clinical cooperation partner
We value the collection of post-market clinical data on our products and for that we rely on our valued cooperation partners. Interested in contributing? Select from one of the research topics we’re currently pursuing below.
Intraoperative Imaging
Brainlab develops numerous technologies to improve cranial and spine surgery navigation by compensating for the intraoperative patient position. Microscope integration helps identify inaccuracies by updating the live patient anatomy. Virtual iMRI elastically morphs the preoperative images to fit the intraoperative images. Universal Automatic Image Registration automatically registers intraoperative images. Loop-X optimizes intraoperative image quality.
Robotic Guided Procedures
Robotic surgical technologies can give you more freedom during your procedures. Whether you’re performing cranial cases like biopsy or spine procedures like minimally invasive pedicle screw placement, robotic surgical assistant Cirq gives you tireless stability throughout.
Surgical Vascular Procedures
Elements Angio Contouring and Elements Cranial Navigation Angio are dedicated tools used to optimize the way surgeons visualize and identify intracranial vascular structures. Interactive, dynamic color-coded contrast flow projections assist with surgical target identification and analysis.
Functional Neurosurgery
Brainlab software leverages advanced imaging for deep brain stimulation procedures, supporting clinicians from preoperative planning through intraoperative targeting accuracy validation to postoperative assessment and therapy fine-tuning. State-of-the-art visualization solutions for lead localization and object identification mean no longer relying on awake reactions from patients and less stressful lead stimulation programming.
Positioning and Monitoring for Radiotherapy
ExacTrac is a room-based patient positioning and monitoring system that can detect intrafraction motion regardless of couch angles and also during beam-on. The new ExacTrac Dynamic system unifies various tracking technologies with a new thermal-surface camera that works in tandem with real-time X-Ray tracking. The hybrid thermal surface correlates the patient’s heat signature to their reconstructed 3D surface structure.