NCT07089758

A Study for Cerebral Open Flow Microperfusion

A Pilot Feasibility Study for Cerebral Open Flow Microperfusion in Patients Undergoing Planned Neurosurgical Resection of Diseased Parenchyma.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Glioma
• Glioblastoma

Interventions

Type	Name	Description
DEVICE	Cerebral open flow microperfusion	Patients will undergo intra-operative microperfusion using Joanneum Research's cerebral open flow microperfusion (OFM) catheters, push and pull tubing, and MPP102-II pump. This process utilizes a probe (catheter) inserted into the parenchyma to collect analytes of any size and polarity from the microenvironment. The microperfusion pump peristaltically pushes and pulls perfusate with no net fluid-exchange when the pump heads are set at equal flow rates. As perfusate enters the tip of the microperfusion catheter, analytes are exchanged based on a gradient between the interstitial fluid and the perfusate. The sample is then recovered via the "pull" portion of the peristaltatic microperfusion pump, enabling constant sampling volumes and preventing loss of the perfusate into the tissue. The duration is 60-80 minutes (dependent on the speed of progress resecting portions of the tumor without catheters)

Timeline

• Start date: 2026-10-01
• Primary completion: 2028-02-01
• Completion: 2028-10-01
• First posted: 2025-07-28
• Last updated: 2026-03-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study