Clinical trial · Observational
Post Market Clinical Follow-up of CODMAN CERTAS Programmable Valve
Post-Market Clinical Follow-up of Patients With CODMAN CERTAS Plus Programmable Valve
NCT05397106CI-TRIAL-00104206active not recruitingClinicalTrials.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)
Post-Market Clinical Follow-up Registry of Patients with CODMAN CERTAS Plus Programmable Valves.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Tumor | Brain Neoplasm | ALIAS | 0.90 |
| Hemorrhagic Stroke | — | UNRESOLVED | — |
| Hydrocephalus | — | UNRESOLVED | — |
| Hydrocephalus in Children | — | UNRESOLVED | — |
| IIH - Idiopathic Intracranial Hypertension | — | UNRESOLVED | — |
| NPH (Normal Pressure Hydrocephalus) | — | UNRESOLVED | — |
| Post-Traumatic Hydrocephalus | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CODMAN CERTAS Plus Programmable Valve | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- CODMAN CERTAS Programmable Valves
- description
- CODMAN CERTAS Plus Programmable Valve, CODMAN CERTAS Plus Small Inline Programmable Valve, and CODMAN CERTAS Plus Right Angle Programmable Valve.
- interventionNames
- Device: CODMAN CERTAS Plus Programmable Valve
Primary outcomes (1)
- measure
- Precise Device Placement: Maintaining Integrity and Functionality at 30 Days Post-Deployment
- timeFrame
- 30 Days
- description
- Device Success is defined as: 1. Deployment with the correct valve positioning 2. Original intended device in place, and 3. No additional surgical or interventional procedures related to access or the device since completion of the original procedure.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1. Patient and/or legally authorized representative has agreed to participate in the study by signing the EC-approved consent form, where applicable. 2. Patients (of any age) who underwent or who plan to have a surgical procedure utilizing one of the Codman CERTAS Plus Programmable Valves. 3. Patient (legally designated representative) is willing to comply with the study protocol timelines \& requirements. 4. For patients who have had the Codman CERTAS Plus Programmable Valve implanted prior to study enrollment, have available data from implantation to the current time. Exclusion Criteria: 1. Patients undergoing implantation of the CODMAN CERTAS Plus Programmable Valve as a revision procedure. 2. Patient's planned shunt has distal drainage to the heart. 3. Patient has ventriculitis, peritonitis or meningitis. 4. Patient has sepsis. 5. Patient has a history of poor wound healing. 6. Patient has symptoms pertaining to a skin infection at or near the site of any incisions; an ear infection on either side; a respiratory tract infection; or a urinary tract infection that, in the Investigator's opinion is clinically significant and might compromise the outcome of this study. 7. Patient has had any form of bowel surgery 30 days prior to device implant or anticipates bowel surgery within 90 days following device implant. 8. Patient is otherwise determined by the Investigator to be medically unsuitable for participation in this study. 9. Patient is currently enrolled in another drug or device trial or has been previously entered in this trial. 10. Patient is a prisoner or member of a different vulnerable population that should not be included in the study per the investigator. 11. Patients with known hypersensitivity to rifampin or clindamycin hydrochloride. This criterion applies for patients to be treated with the BACTISEAL Catheters (included in some models of the valve) only.
References
Publications (0)
Data not yet available
No reference posted for this study.