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NCT03594136

New Reference Values for Intracranial Pressure

Completed NA Last updated 23 January 2024
What this trial tests

NA trial testing Raumedic Neurovent-P-tel in Intracranial Pressure in 6 participants. Completed in 1 May 2023.

Timeline
1 February 2018
Primary endpoint
1 May 2023
1 May 2023

Quick facts

Lead sponsorRigshospitalet, Denmark
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposebasic science
Enrollment6
Start date1 February 2018
Primary completion1 May 2023
Estimated completion1 May 2023
Sites3 locations across Denmark, Czechia

Drugs / interventions tested

Conditions studied

Sponsor

Rigshospitalet, Denmark

Who can join

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

Sponsor's own description

Intracranial pressure is a cornerstone in neurosurgical care used in a variety of diseases. However currently, doubts regarding normal intracranial pressure exist. Few studies have investigated normal intracranial pressure in truly normal adults. The aim of this study is to investigate intracranial pressure in adults who have normal intracranial pressure physiology. In this prospective, multicenter, clinical study, the intracranial pressure of 10 adults requiring surgery for an unruptured aneurysm will be investigated. These patients are thought to be normal in terms of intracranial pressure physiology. At the end of their surgery for an aneurysm, a telemetric intracranial pressure monitoring sensor will be implanted. Afterward, intracranial pressure curves will be obtained non-invasively 1., 14., 30 and 90 days after implantation. The intracranial pressure will be investigated in 5 different positions (supine, lumbar, upright sitting, standing and walking). Furthermore, a 24-hour measurement will be performed in their home environment, thus investigating intracranial pressure under daily activities.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. The Current State of Clinical Trials Studying Hydrocephalus: An Analysis of ClinicalTrials.gov.
    Abraham ME, Povolotskiy R, Gold J, Ward M, et al · · 2020 · cited 3× · PMID 32983722 · DOI 10.7759/cureus.10029
  2. Intracranial pressure following surgery of an unruptured intracranial aneurysm-a model for normal intracranial pressure in humans.
    Norager NH, Lilja-Cyron A, Riedel CS, Holst AV, et al · · 2024 · PMID 38773608 · DOI 10.1186/s12987-024-00549-1

Verify or expand the search:

Other recruiting trials for Intracranial Pressure

Currently open trials in the same condition.

Other Rigshospitalet, Denmark trials

Trials by the same sponsor.

Verify against primary sources

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/NCT03594136.

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