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NCT03641443: aICPTumor

non_invasive_aICP_Tumor

Completed NA Last updated 26 February 2020
What this trial tests

NA trial testing Non-invasive measurement of intracranial pressure in Tumor, Brain in 48 participants. Completed in 31 December 2019.

Timeline
12 September 2016
Primary endpoint
31 December 2019
31 December 2019

Quick facts

Lead sponsorKantonsspital Aarau
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposediagnostic
Enrollment48
Start date12 September 2016
Primary completion31 December 2019
Estimated completion31 December 2019
Sites1 location across Switzerland

Drugs / interventions tested

Conditions studied

Sponsor

Kantonsspital Aarau — full company profile →

Who can join

18 and older, any sex, with Tumor, Brain or Intracranial Pressure Increase. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Changing the paradigm of intracranial hypertension in brain tumor patients: a study based on non-invasive ICP measurements.
    Kienzler JC, Zakelis R, Marbacher S, Bäbler S, et al · · 2020 · cited 8× · PMID 32631262 · DOI 10.1186/s12883-020-01837-7

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Other recruiting trials for Tumor, Brain

Currently open trials in the same condition.

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Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03641443.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing