Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to gather information about post-market performance of DuraGen Secure.The aim of this post market clinical follow-up (PMCF) is to obtain post market clinical data to evaluate the presence of unintended residual risks associated with the use of DuraGen Secure that were not anticipated or identified in the animal studies, bench studies or clinical evaluation report.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Duragen Secure | Have undergone a neurosurgical procedure where DuraGen® Secure has been implanted |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Patient's Outcome | Patient outcome from the procedure (recovered without sequelae, ongoing with medical intervention, ongoing with surgical intervention, deceased, other) | Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Occurence of Adverse Event | Adverse event that occured 72 hours post-operatively | first 72 hours post-op |
| Occurence of Adverse Event | Adverse event that occured between days 4-14 post-operatively |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Neurgosurgery service in Hospital
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Lariboisière | Paris | France | ||||
| die Charité - Universitätsmedizin Berlin |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Duragen Secure | Have undergone a neurosurgical procedure where DuraGen® Secure has been implanted |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Duragen Secure | Have undergone a neurosurgical procedure where DuraGen® Secure has been implanted |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patient's Outcome | Patient outcome from the procedure (recovered without sequelae, ongoing with medical intervention, ongoing with surgical intervention, deceased, other) | Posted | Count of Participants | Participants | Day 30 |
|
|
Retrospective chart review of AE occured between surgery (Day 0) and file completion (between Day 30 and Day 60)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Duragen Secure | Have undergone a neurosurgical procedure where DuraGen® Secure has been implanted |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Global Clinical Affairs | Integra LifeSciences Corporation | 609-936-5490 | andrew.tummon@integralife.com |
Not provided
| ID | Term |
|---|---|
| D022125 | Lacerations |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
Not provided
Not provided
Not provided
Not provided
Not provided
| between days 4-14 |
| Occurence of Adverse Event | Adverse event that occured between days 15-30 post-operatively | Between days 15-30 |
| Berlin |
| Germany |
| Hospital Universitario 12 de Octubre | Madrid | Spain |
| Hospital Universitario La Fe | Valencia | Spain |
| National Hospital for Neurology and Neurosurgery | London | United Kingdom |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
| Secondary | Occurence of Adverse Event | Adverse event that occured 72 hours post-operatively | Posted | Count of Participants | Participants | first 72 hours post-op |
|
|
|
| Secondary | Occurence of Adverse Event | Adverse event that occured between days 4-14 post-operatively | Posted | Count of Participants | Participants | between days 4-14 |
|
|
|
| Secondary | Occurence of Adverse Event | Adverse event that occured between days 15-30 post-operatively | Posted | Count of Participants | Participants | Between days 15-30 |
|
|
|
| 3 |
| 100 |
| 31 |
| 100 |
| 0 |
| 100 |
| Cardiac arrhythmia | Cardiac disorders | MedDRA (17.1) | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Inflammatory reaction | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| Wound healing disturbance | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| Death | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| Weakness worsened | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
|
| Meningitis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
|
| subdural empyema | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
|
| Shunt infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
|
| cerebral empyema | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
|
| Bronchopneumonia | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
|
| Bladder infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
|
| Wound Infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
|
| Anemia postoperative | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
|
| Postoperative bleeding | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
|
| Graft failure | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
|
| Cardiac enzymes increased | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| Lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.1) | Systematic Assessment |
|
| Neoplasm recurrence | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.1) | Systematic Assessment |
|
| CSF leakage | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| Haematoma cerebral | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| Intracranial haemorrhage | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| Seizure | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| Subdural Hygroma | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| Hydrocephalus | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| Paraparesis | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| Hemiparesis | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| Hemorrhage intracranial | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| Intracranial hypertension | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| Dysarthria | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| Cerebrospinal fluid leakage | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| Organic brain syndrome | Psychiatric disorders | MedDRA (17.1) | Systematic Assessment |
|
| Renal insufficiency | Renal and urinary disorders | MedDRA (17.1) | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Lung edema | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Brain tumor operation | Surgical and medical procedures | MedDRA (17.1) | Systematic Assessment |
|
| Thrombosis venous deep | Vascular disorders | MedDRA (17.1) | Systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA (17.1) | Systematic Assessment |
|
Not provided