Clinical trial NCT05397106: Post Market Clinical Follow-up of CODMAN CERTAS Programmable Valve
Official title: Post-Market Clinical Follow-up of Patients With CODMAN CERTAS Plus Programmable Valve
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hydrocephalus
Hydrocephalus in Children
NPH (Normal Pressure Hydrocephalus)
IIH - Idiopathic Intracranial Hypertension
Brain Tumor
Post-Traumatic Hydrocephalus
Hemorrhagic Stroke
Lead sponsor: Integra LifeSciences Corporation
Sponsor class: INDUSTRY
First posted: 2022-05-31
Enrollment: 158
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patients of any age, gender, and ethnicity, with hydrocephalus.

Patients will receive the CODMAN CERTAS Plus Programmable Valve type most applicable for their condition, as determined by their clinician.

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Precise Device Placement: Maintaining Integrity and Functionality at 30 Days Post-Deployment
timeFrame: 30 Days
Secondary outcomes:
Other outcomes:
measure: Incidence of Valve Replacement
timeFrame: 12, 24 and 36 Months
measure: Adverse Events
timeFrame: 12, 24 and 36 Months
measure: Number of encounters with inadvertent reprogramming of CODMAN CERTAS Plus Programmable Valves
timeFrame: 12, 24 and 36 Months
Locations:
city: Leuven
country: Belgium
facility: University Hospital Leuven
city: Roeselare
country: Belgium
facility: AZ Delta - Roeselare
city: Dortmund
country: Germany
facility: Klinikum Dortmund Wirbelsäulenchirurgie
city: Düsseldorf
country: Germany
facility: Heinrich Heine University, Dept of Neurosurgery, Universitätsklinik Düsseldorf
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Freiburg
country: Germany
facility: Freiburg University Hospital
city: Stuttgart
country: Germany
facility: Katharinenhospital - Neurochirurgische Klinik Stuttgart
city: Madrid
country: Spain
facility: Hospital12 de Octubre
city: St. Gallen
country: Switzerland
facility: Canton Hospital St. Gallen
Study officials:
affiliation: Integra LifeSciences
name: Sherese Fralin, MSN, FNP, PhD
role: STUDY_DIRECTOR
References: