Clinical trial · Interventional
Multicenter Safety Trial Assessing an Innovative Tumor Molecular and Cellular Print Medical Device in Glioma
Molecular and Cellular Print Medical Device Validation in Adult Glioma Tumors
NCT02077543CI-TRIAL-00044248ProToolunknownEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of the study is to determine the clinical safety and operability of the innovative tissue imprint device ProTool.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioma : Oligodendroglioma or Astrocytoma | Astrocytoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brain Tissue Imprint - Medical Device (ProTool) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ProTool
- description
- Device: Brain Tissue Imprint - Medical Device (ProTool)
- interventionNames
- Device: Brain Tissue Imprint - Medical Device (ProTool)
Primary outcomes (3)
- measure
- Clinical examination : neurologic deficiency, allergic reaction, infections, pain, headaches, others adverse events... Postoperative MRI evaluation : no hematoma
- timeFrame
- 2 hours after surgery
- measure
- Clinical examination : neurologic deficiency, allergic reaction, infections, pain, headaches, others adverse events... Postoperative MRI evaluation : no hematoma
- timeFrame
- one month after surgery
- measure
- Clinical examination : neurologic deficiency, allergic reaction, infections, pain, headaches, others adverse events... Postoperative MRI evaluation : no hematoma
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * more or equal than 18 years old * patient affiliated to social security or similarly regime * informed consent form signed * glial tumor suspicion * Stereotaxic biopsy indication * Karnofsky score \> 70% * Hematological assessment : * neutrophils \> 1500/mm3 * Platelet \> 150 000 * blood Creatinin normal * alkaline Phosphatases and transaminases no more than two times normal * Bilirubin \< 1.5 times normal Exclusion Criteria: * Pregnant women and lactating mothers * Ward of court or under guardianship * Adult unable to express their consent * Person deprived of freedom by judicial or administrative decision * Person hospitalized without their consent * Person under legal protection * Person participating in another clinical study * Intratumoral hemorrhage MRI detected * Treatment anticoagulant or antisludge treatments * Active Infections and non controled or medical affection or psychiatric intercurrent non treated * Evolutive cerebral oedema without corticoid response * Non controled Epilepsy without antiepileptics response * Susceptibility to Medical Device materials allergy
References
Publications (0)
Data not yet available
No reference posted for this study.