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JOURNAL ONKOLOGIE – STUDIE

Post Market Clinical Follow-up of CODMAN CERTAS Programmable Valve

Rekrutierend

NCT-Nummer:
NCT05397106

Studienbeginn:
Januar 2023

Letztes Update:
04.12.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Hydrocephalus, Intracranial Hypertension, Hemorrhagic Stroke, Hydrocephalus, Normal Pressure, Pseudotumor Cerebri

Geschlecht:
Alle

Altersgruppe:
Alle

Phase:
-

Sponsor:
Integra LifeSciences Corporation

Collaborator:
-

Studienleiter

Sherese Fralin, MSN, FNP, PhD
Study Director
Integra LifeSciences

Kontakt

Studienlocations
(3 von 6)

Heinrich Heine University, Dept of Neurosurgery, Universitätsklinik Düsseldorf
40225 Düsseldorf
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Thomas Beez, MD
Phone: +49 211 81 07664
E-Mail: thomas.beez@med.uni-duesseldorf.de

Fljamur Aljiji, SC
E-Mail: Fljamur.Aljiji@med.uni-duesseldorf.de» Ansprechpartner anzeigen
AZ Delta - Roeselare
Roeselare
BelgiumNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Dimitri Vanhauwaert, MD
Phone: + 32 51 237440
E-Mail: dimitri.vanhauwaert@azdelta.be

Stijn Van Damme, SC
Phone: + 32 51 237449
E-Mail: stijn.vandamme@azdelta.be» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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.

Studien-Rationale

Primary outcome:

1. Device success - Time Frame: Days (Time Frame - 30 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.

Geprüfte Regime

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

Quelle: ClinicalTrials.gov


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