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A Study for Cerebral Open Flow Microperfusion

NCT07089758 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2026-03-23

No results posted yet for this study

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

Interventions

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)

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Terence Burns, MD · Mayo Clinic

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-31
Primary Completion
2028-02-29
Completion
2028-10-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07089758 on ClinicalTrials.gov