Status:
COMPLETED
Implant System for Fixation of Cranial Bone Flaps After Craniotomy for Brain Surgery
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Skull Fixation After Craniotomy for Neurosurgical Procedures
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Bone flaps after craniotomy are typically fixed with suture material, mini plates and others devices. In some cases, fixation with suture material is not secure as it may result in shifting of the bon...
Detailed Description
At the end of the operation to start the fixation of cranial bone flaps, at least three Skull Grip titanium clamps will be positioned equidistant to one another along the craniotomy opening. The lower...
Eligibility Criteria
Inclusion
- Major patient (aged ≥ 18 years)
- Patient scheduled for craniotomy for a benign tumor
- Patient informed and have signed informed consent
Exclusion
- Patient not affiliated with a social security scheme (or beneficiary entitled)
- Patient with a known allergy to titanium
- Patient non-compliant or whose follow-up to 3 months is impossible
- Patient with against-indication scanner
- Pregnant or lactating
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00797979
Start Date
October 1 2009
End Date
July 1 2010
Last Update
November 27 2012
Active Locations (1)
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1
CHU Lariboisière, AP-HP, Neurochirurgie
Paris, Île-de-France Region, France, 75010