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Space Flap for Cerebral Protection Following Decompressive Hemicraniectomy for Stroke

NCT04865757 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2021-04-29

No results posted yet for this study

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.

Conditions

  • Infarction

Interventions

DEVICE

Space Flap

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

Sponsors & Collaborators

  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Principal Investigators

  • Schucht Philippe, MD · Dep. of Neurosurgery, Bern University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2020-08-31
Completion
2020-09-30

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 NCT04865757 on ClinicalTrials.gov