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
This post-market follow-up registry will capture clinical data specific to the safety and performance of the Integra External Ventricular Drainage Systems and Accessories.
The purpose of this study is to investigate whether the Integra External Ventricular Drainage System listed as part of this study do perform to clinical expectations.
Additionally, this study will focus on the safety of these devices by collecting any device-specific Adverse Events (AEs) or Device deficiencies (DDs) seen when used during standard of care procedures.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| External Ventricular Drainage (EVD) | Device | EVD of Cerebral Spinal Fluid from the lateral ventricles of the brain |
| Measure | Description | Time Frame |
|---|---|---|
| Anticipated Drainage of Cerebrospinal Fluid (CSF) | Percentage of subjects with anticipated drainage (i.e., observed drainage consistent with the patient's clinical presentation) of cerebrospinal fluid (CSF) in the clinical setting until the EVD System is no longer required. | 1 month following device implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Success of the Access to the Intracranial Space | Percentage of subjects in whom the CODMAN Cranial Access Kit, when used with appropriate accessories, provided successful access to the intracranial space. | 1 month following device implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Device- or Procedure Related Adverse Events (AEs) During the Use of the Device in the Patient | Percentage of subjects with device related adverse events (AEs) during the use of the device in the patient | 1 month following device implantation |
| Noted Device Deficiencies During Use of the Device Such as Malfunction, Use Errors, or Other Issues Related to the Performance or Safety of the External Ventricular Drainage Systems and Accessories |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Consecutive patients of any age, and gender who underwent a procedure with one of the Integra External Ventricular Drainage Systems or Accessories
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jason Marzuola | Integra LifeSciences Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziekenhuis Oost-limburg | Genk | 3600 | Belgium | |||
| University Hospitals leuven |
A total of 120 patients, ie, the full consecutive series of patients from study sites were screened, and 117 subjects were included in this study.
Consecutive subjects of any age, and gender who gave consent for study participation, and who met the eligibility criteria and, who underwent a procedure with one of the Integra External Ventricular Drainage Systems or Accessories were enrolled into the study. The enrollment occured at at four sites in EU: three in Belgium and one in France.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Subject Underwent a Procedure With One Integra External Ventricular Drainage System or Accessorie. | Consecutive subjects of any age, and gender who gave consent for study participation, and who met the eligibility criteria and, who underwent a procedure with one of the Integra External Ventricular Drainage Systems or Accessories were enrolled into the study. The enrollment occured at at four sites in EU: three in Belgium and one in France. A total of 120 patients, ie, the full consecutive series of patients from study sites were screened, and 117 subjects were included in this study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Subject Underwent a Procedure With one of the Integra External Ventricular Drainage Systems or Accessories.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Subject Underwent a Procedure With One Integra External Ventricular Drainage System or Accessorie. | Consecutive subjects of any age, and gender who gave consent for study participation, and who met the eligibility criteria and, who underwent a procedure with one of the Integra External Ventricular Drainage Systems or Accessories were enrolled into the study. The enrollment occured at at four sites in EU: three in Belgium and one in France. A total of 120 patients, ie, the full consecutive series of patients from study sites were screened, and 117 subjects were included in this study. |
| 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 | Anticipated Drainage of Cerebrospinal Fluid (CSF) | Percentage of subjects with anticipated drainage (i.e., observed drainage consistent with the patient's clinical presentation) of cerebrospinal fluid (CSF) in the clinical setting until the EVD System is no longer required. | Subject underwent a procedure with one of the Integra External Ventricular Drainage Systems or Accessories. | Posted | Count of Participants | Participants | 1 month following device implantation |
|
Adverse Event information were collected on any adverse event that the subject experienced within 1 month following device implantation.
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 | Subject Underwent a Procedure With One Integra External Ventricular Drainage System or Accessorie. | Consecutive subjects of any age, and gender who gave consent for study participation, and who met the eligibility criteria and, who underwent a procedure with one of the Integra External Ventricular Drainage Systems or Accessories were enrolled into the study. The enrollment occured at at four sites in EU: three in Belgium and one in France. A total of 120 patients, ie, the full consecutive series of patients from study sites were screened, and 117 subjects were included in this study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew Tummon | Integra LifeSciences | +1 (609) 936-5490 | andrew.tummon@integralife.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 11, 2024 | Dec 11, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 11, 2024 | Dec 11, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D002493 | Central Nervous System Diseases |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Percentage of subjects with noted Device Deficiencies during use of the device such as malfunction, use errors, or other issues related to the performance or safety of the External Ventricular Drainage Systems and Accessories |
| 1 month following device implantation |
| Leuven |
| 3000 |
| Belgium |
| AZ Delta | Roeselare | 8000 | Belgium |
| Hôpital Gui de Chauliac | Montpellier | 34295 | France |
| 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 |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Success of the Access to the Intracranial Space | Percentage of subjects in whom the CODMAN Cranial Access Kit, when used with appropriate accessories, provided successful access to the intracranial space. | Posted | Count of Participants | Participants | 1 month following device implantation |
|
|
|
| Other Pre-specified | Device- or Procedure Related Adverse Events (AEs) During the Use of the Device in the Patient | Percentage of subjects with device related adverse events (AEs) during the use of the device in the patient | Subject underwent a procedure with one of the Integra External Ventricular Drainage Systems or Accessories. | Posted | Count of Participants | Participants | 1 month following device implantation |
|
|
|
| Other Pre-specified | Noted Device Deficiencies During Use of the Device Such as Malfunction, Use Errors, or Other Issues Related to the Performance or Safety of the External Ventricular Drainage Systems and Accessories | Percentage of subjects with noted Device Deficiencies during use of the device such as malfunction, use errors, or other issues related to the performance or safety of the External Ventricular Drainage Systems and Accessories | Subject underwent a procedure with one of the Integra External Ventricular Drainage Systems or Accessories. | Posted | Count of Participants | Participants | 1 month following device implantation |
|
|
|
| 10 |
| 117 |
| 59 |
| 117 |
| 54 |
| 117 |
| Anaemia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Atrioventricular block complete | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Cardiac tamponade | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Brain death | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Condition aggravated | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Multiple organ dysfunction syndrome | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Oedema | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hepatic haemorrhage | Hepatobiliary disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Bacterial infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Clostridium difficile colitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| CNS ventriculitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Device related sepsis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Meningitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Postoperative wound infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Brain herniation | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Unintentional medical device removal | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Wound haemorrhage | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Wound secretion | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Bacterial test positive | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| CSF cell count increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| CSF volume increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Cerebral salt-wasting syndrome | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Brain injury | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Brain oedema | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Cerebellar haematoma | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Cerebral vasoconstriction | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Cerebrospinal fluid leakage | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hydrocephalus | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Intracranial pressure increased | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Speech disorder | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Vertebrobasilar insufficiency | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Device dislocation | Product Issues | MedDRA (Unspecified) | Systematic Assessment |
|
| Device leakage | Product Issues | MedDRA (Unspecified) | Systematic Assessment |
|
| Device occlusion | Product Issues | MedDRA (Unspecified) | Systematic Assessment |
|
| Product contamination | Product Issues | MedDRA (Unspecified) | Systematic Assessment |
|
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Wound drainage | Surgical and medical procedures | MedDRA (Unspecified) | Systematic Assessment |
|
| Surgery | Surgical and medical procedures | MedDRA (Unspecified) | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Shock haemorrhagic | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Vasospasm | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Ear swelling | Ear and labyrinth disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Haematotympanum | Ear and labyrinth disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Complication associated with device | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| CNS ventriculitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Erysipelas | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Nosocomial infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Pneumonia aspiration | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Cerebral ventricle dilatation | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Cerebrospinal fluid leakage | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Cognitive disorder | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Haemorrhage intracranial | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Intracranial pressure increased | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Partial seizures | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Status epilepticus | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Subdural hygroma | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Device dislocation | Product Issues | MedDRA (Unspecified) | Systematic Assessment |
|
| Device occlusion | Product Issues | MedDRA (Unspecified) | Systematic Assessment |
|
| Product contamination | Product Issues | MedDRA (Unspecified) | Systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Disorientation | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Vasospasm | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
Not provided
Not provided