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non_invasive_aICP_Tumor

NCT03641443 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2020-02-26

No results posted yet for this study

Summary

Since decades, neurosurgeons and neurooncologists assumed that the mass effect of brain tumors with peritumoral edema or intratumoral hemorrhage might lead to increased ICP. Therefore, decisions on surgical procedures and medical treatments were made based on clinical and radiological findings suggesting increased ICP. But in fact, no measurement has ever confirmed increased ICP in brain tumor patients. From an ethical point of view, it is not justifiable to implant an intraparenchymal ICP probe within an invasive surgical procedure in a brain tumor patient unless the patient is comatose or present with rapid impairment of the level of consciousness. Therefore, with the new medical device for non-invasive ICP measurement presented in this study protocol, we will be able to measure absolute ICP values in patients with brain tumors.

Conditions

  • Tumor, Brain
  • Intracranial Pressure Increase

Interventions

DEVICE

Non-invasive measurement of intracranial pressure

Non-invasive measurement of intracranial pressure in patients with mass effective brain Tumors

Sponsors & Collaborators

  • Kantonsspital Aarau

    lead OTHER

Principal Investigators

  • Jenny Kienzler, MD · Kantonsspital Aarau

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-12
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • Switzerland

Study Locations

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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 NCT03641443 on ClinicalTrials.gov