CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 10 enrolled
Drug / intervention
Space Flapdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04865757
NCT04865757N/ACompleted

Space Flap for Cerebral Protection Following Decompressive Hemicraniectomy for Stroke

Insel Gruppe AG, University Hospital Bern·interventional·Posted Apr 29, 2021·Updated Apr 29, 2021

In Brief

A clinical study evaluating Space Flap for Infarction. Completed, enrolled 10 participants across 1 site.

Detailed Summary

In this study the investigators want to investigate to what extent the application of an artificial bone flape (space flap) influences the success of a decompressive craniectomy. In all participants, a space flap is placed immediately after removal of the skull cap. In a second operation, after 1-3 months, an operation is performed, in which the stored own skull bone is re-inserted. The artificial bone cover is removed at this point.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfarction
CountriesSwitzerland
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 29, 2021
Enrollment StartJul 1, 2012
Primary CompletionAug 1, 2020
Study CompletionSep 1, 2020
TodayJul 2, 2026
Enrollment to primary: 8.1 yearsPosted 5.2 years ago

Interventions

Space Flapdevice

A space flap is formed out of Palacos®, adjusted to the skull surface with temporal augmentation