Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
6 participants
INTERVENTIONAL
2018-02-01
2023-05-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Telemetric intracranial pressure implant
A telemetric intracranial pressure monitoring sensor is inserted into the brain parenchyma at the end of an uncomplicated surgery for an unruptured aneurysm
Raumedic Neurovent-P-tel
Insertion of a Neurovent-P-tel in adults to study normal intracranial pressure
Interventions
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Raumedic Neurovent-P-tel
Insertion of a Neurovent-P-tel in adults to study normal intracranial pressure
Eligibility Criteria
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Inclusion Criteria
* Requiring surgery for a "cold" (unruptured) aneurysm
Exclusion Criteria
* Current or previous examination or treatment for idiopathic intracranial hypertension
* Previous operation with insertion of cerebrospinal fluid shunt
* Previous trauma with intracranial hemorrhage
* Global cerebral edema
* Increased infection risks
* Surgical complications during the primary operation
* Unable to understand patient information
18 Years
ALL
Yes
Sponsors
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Lundbeck Foundation
OTHER
Rigshospitalet, Denmark
OTHER
Responsible Party
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Nicolas Alexander Norager
Researh Assistant
Principal Investigators
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Marianne Marianne, D.M.Sc.
Role: STUDY_DIRECTOR
Rigshospitalet, Denmark
Locations
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Military University Hospital Prague
Prague, , Czechia
Rigshospitalet
Copenhagen, Copenhagen E, Denmark
Aarhus University Hospital
Aarhus, , Denmark
Countries
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References
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Norager NH, Lilja-Cyron A, Riedel CS, Holst AV, Pedersen SH, Juhler M. Intracranial pressure following surgery of an unruptured intracranial aneurysm-a model for normal intracranial pressure in humans. Fluids Barriers CNS. 2024 May 21;21(1):44. doi: 10.1186/s12987-024-00549-1.
Other Identifiers
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P1NICP
Identifier Type: -
Identifier Source: org_study_id
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