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Study stopped by local authorities
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Purpose of the study is to answer the question whether confocal laser endomicroscopy (CLE, also named 'optical biopsy') might improve the results of medically necessary neurosurgery to prove practicability, safety and harmlessness of CLE during neurosurgical procedures
In patients requiring neurosurgical oncological Intervention using endoscopic devices, a mini laser probe will be administered through the endoscopic device to characterize in vivo the tissue by thousandfold magnification down to the cellular level (so-called optical biopsy). Magnification is presented to the neurosurgeon in time to better differentiate between healthy and pathological tissue. Post-surgery results of in-vivo Differentiation will then be compared to histocytopathological findings.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cellvizio mini laser probe | Cellvizio mini laser probe will be administered via the endoscopic device used for the neurosurgical procedure to provide confocal laser endomicroscopy in patients requiring neurosurgery due to glioma multiforme or subcranial tumors |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cellvizio mini laser probe | Other | Cellvizio mini laser probe is administered via the endoscopic device used during the neurosurgical procedures to provide the optical biopsy |
|
| Measure | Description | Time Frame |
|---|---|---|
| post-surgery comparison of in-vivo tissue characterization with ex-vivo histocytopathology | duration of hospital stay, an expected average of 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| proof of complete removal of pathologic tissue within healthy tissue | during surgical procedure, an expected average time of three hours | |
| optimal tumour remission or reduction after 3 months post-surgery proven by respective diagnostic measurements | 3 months post surgery |
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Inclusion Criteria:
Exclusion Criteria:
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patients suffering from either subcranial Tumors or cerebral gliomata
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| Name | Affiliation | Role |
|---|---|---|
| Cleopatra Charalampaki, MD Prof | Department Neurosurgery, Hospital Koeln-Merheim | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinic of Neurosurgery, Hospital of Cologne | Cologne-Merheim | North Rhine Westfalia | 51109 | Germany |
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| Composite measure of missing iatrogenic damage of healthy neuronal structures and preservation of functionality of healthy tissue | individual post-surgery controls, an expected average of up to 7 days |