NCT06638385 A Space-expanding Shield in Decompressive Hemicraniectomy for Stroke
| NCT ID | NCT06638385 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Insel Gruppe AG, University Hospital Bern |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2025-06-01 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 110 participants in total. It began in 2025-06-01 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Instead of the standard decompressive hemicraniectomy with subsequent cranioplasty a single surgery with the implantation of an individually molded space-expanding shield is investigated in for patients with increased intracranial pressure due to a malignant stroke.
Eligibility Criteria
Inclusion Criteria: * Patients with malignant infarction of the middle cerebral artery identified by MRI including diffusion-weighted imaging or CT including perfusion imaging - fulfilling the European guidelines for decompressive hemicraniectomy (DCE) for stroke * ≥ 18 and \< 70 years of age * Availability of consent from a next of kin and from the patient represented by an independent physician Exclusion Criteria: * Hyperacute need for DCE due to rapid neurological decline * Contraindications to the use of polymethyl-methacrylate (PMMA), e.g., known hypersensitivity, allergy * Known gentamicin allergy * Pregnancy and active breast-feeding * Patients with a former history of DCE and/or CP * Active pulmonary or cranial infection * Known coagulopathy independent of medication
Contact & Investigator
Schucht Philippe, MD
PRINCIPAL INVESTIGATOR
Inselspital Bern, Department of Neurosurgery
Frequently Asked Questions
Who can join the NCT06638385 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06638385 currently recruiting?
Yes, NCT06638385 is actively recruiting participants. Contact the research team at philippe.schucht@insel.ch for enrollment information.
Where is the NCT06638385 trial being conducted?
This trial is being conducted at Aarau, Switzerland, Basel, Switzerland, Bern, Switzerland, Lucerne, Switzerland and 2 additional locations.
Who is sponsoring the NCT06638385 clinical trial?
NCT06638385 is sponsored by Insel Gruppe AG, University Hospital Bern. The principal investigator is Schucht Philippe, MD at Inselspital Bern, Department of Neurosurgery. The trial plans to enroll 110 participants.
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