Post Market Clinical Follow-up of CODMAN CERTAS Programmable Valve

Brain Tumor Clinical Trial

Official title:

Post-Market Clinical Follow-up of Patients With CODMAN CERTAS Plus Programmable Valve

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05397106
• Other study ID #: C-CERTAS-002
• Status: Recruiting
• Start date: January 24, 2023
• Est. completion date: September 30, 2027

Study information

• Verified date: November 2023
• Source: Integra LifeSciences Corporation
• Contact: Maria Salmon-Sargeant
• Phone: 339-206-2979
• Email: maria.salmonsargeant[@]integralife.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Post-Market Clinical Follow-up Registry of Patients with CODMAN CERTAS Plus Programmable Valves.

Description:

The CODMAN CERTAS Plus Programmable Valve is a single use implantable device designed for shunting cerebrospinal fluid (CSF) for the treatment of hydrocephalus.

The valve can be set to 8 different performance settings for intraventricular pressure and drainage of CSF. The performance setting of the valve can be set preoperatively and can also be noninvasively changed post-implantation.

This clinical investigation will maintain data for each patient from the date of implant through 3 years post-implantation.

Data collection for each patient will occur per standard of care.

However, the clinical investigation specifically aims to collect and analyze data from the day of procedure, and post-operatively at 1 month, 3 months, 6 months, 12 months, 24 months, and 36 months.

Data from follow-up visits will be analyzed according to pre-defined time-intervals referring to these follow-up moments.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 158
• Est. completion date: September 30, 2027
• Est. primary completion date: August 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Tumor
• Hemorrhagic Stroke
• Hydrocephalus
• Hydrocephalus in Children
• Hydrocephalus, Normal Pressure
• IIH - Idiopathic Intracranial Hypertension
• Intracranial Hypertension
• NPH (Normal Pressure Hydrocephalus)
• Pseudotumor Cerebri

Intervention

Device:
• CODMAN CERTAS Plus Programmable Valve
Patients will undergo implantation of the CODMAN CERTAS Plus Programmable Valve according to the device label.

Locations

Country	Name	City	State
Belgium	AZ Delta - Roeselare	Roeselare
Germany	Klinikum Dortmund Wirbelsäulenchirurgie	Dortmund
Germany	Heinrich Heine University, Dept of Neurosurgery, Universitätsklinik Düsseldorf	Düsseldorf
Germany	Universitätsklinikum Essen	Essen
Germany	Freiburg University Hospital	Freiburg
Germany	Katharinenhospital - Neurochirurgische Klinik Stuttgart	Stuttgart

Sponsors (1)

Lead Sponsor	Collaborator
Integra LifeSciences Corporation

Countries where clinical trial is conducted

Belgium,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of Valve Replacement	Incidence of Valve replacement post - implantation	12, 24 and 36 Months
Other	Adverse Events	Incidence of Adverse Events post - implantation; Long term safety will be assessed by the incidence of all adverse events/complications including number of subjects with shunt and/or shunt system infections.	12, 24 and 36 Months
Other	Number of encounters with inadvertent reprogramming of CODMAN CERTAS Plus Programmable Valves	Incidence of inadvertent reprogramming of CODMAN CERTAS Plus Programmable Valves post - implantation prior to MRI	12, 24 and 36 Months
Primary	Device success - Time Frame: Days	Device Success is defined as: Deployment with the correct valve positioning; Original intended device in place, and; No additional surgical or interventional procedures related to access or the device since completion of the original procedure.	30 Days