A Study for Cerebral Open Flow Microperfusion
Status
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
The purpose of this study is to evaluate the safety and feasibility of intra-operative microperfusion during a planned neurosurgical resection of diseased brain parenchyma, including either an epileptic focus requiring temporal lobectomy or a glioma. Devices used for microperfusion are Joanneum Research cerebral open flow microperfusion (OFM) catheters, push and pull tubing, and MPP102-II pump.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion Criteria
- ECOG performance status (PS) 0, 1 or 2.
- Clinical and radiographic evidence diagnosis of glioma, or a prior diagnosis of glioma (suspected WHO grade II-IV), OR clinical evidence of epileptic foci requiring a temporal lobectomy.
- Clinical indication for resection as part of routine clinical care, with plan for this to be performed at Mayo Clinic (Rochester, MN).
- Able and willing to provide informed consent either signed by themselves or a legally authorized representative.
Exclusion Criteria
- Vulnerable populations: pregnant women, prisoners or the mentally handicapped.
- Patients who are not appropriate candidates for surgery due to current or past medical history or uncontrolled concurrent illness.
- Patients whom the surgeon deems to be at increased risk of adverse effects from the study.
Trial design
Primary purpose
Allocation
Interventional model
Masking
6 participants in 1 patient group
Trial contacts and locations
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Central trial contact
Neurologic Surgery Research Team
Data sourced from clinicaltrials.gov
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