Post Market Clinical Follow-up of CODMAN CERTAS Programmable Valve

Last updated: November 19, 2024
Sponsor: Integra LifeSciences Corporation
Overall Status: Active - Recruiting

Phase

N/A

Condition

Brain Tumor

Blood Clots

Stroke

Treatment

CODMAN CERTAS Plus Programmable Valve

Clinical Study ID

NCT05397106
C-CERTAS-002
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patient and/or legally authorized representative has agreed to participate in thestudy by signing the EC-approved consent form, where applicable.

  2. Patients (of any age) who underwent or who plan to have a surgical procedureutilizing one of the Codman CERTAS Plus Programmable Valves.

  3. Patient (legally designated representative) is willing to comply with the studyprotocol timelines & requirements.

  4. For patients who have had the Codman CERTAS Plus Programmable Valve implanted priorto study enrollment, have available data from implantation to the current time.

Exclusion

Exclusion Criteria:

  1. Patients undergoing implantation of the CODMAN CERTAS Plus Programmable Valve as arevision 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 anyincisions; an ear infection on either side; a respiratory tract infection; or aurinary tract infection that, in the Investigator's opinion is clinicallysignificant and might compromise the outcome of this study.

  7. Patient has had any form of bowel surgery 30 days prior to device implant oranticipates bowel surgery within 90 days following device implant.

  8. Patient is otherwise determined by the Investigator to be medically unsuitable forparticipation in this study.

  9. Patient is currently enrolled in another drug or device trial or has been previouslyentered in this trial.

  10. Patient is a prisoner or member of a different vulnerable population that should notbe included in the study per the investigator.

  11. Patients with known hypersensitivity to rifampin or clindamycin hydrochloride. Thiscriterion applies for patients to be treated with the BACTISEAL Catheters (includedin some models of the valve) only.

Study Design

Total Participants: 158
Treatment Group(s): 1
Primary Treatment: CODMAN CERTAS Plus Programmable Valve
Phase:
Study Start date:
January 24, 2023
Estimated Completion Date:
September 30, 2027

Study 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.

Connect with a study center

  • University Hospital Leuven

    Leuven,
    Belgium

    Active - Recruiting

  • AZ Delta - Roeselare

    Roeselare,
    Belgium

    Active - Recruiting

  • Klinikum Dortmund Wirbelsäulenchirurgie

    Dortmund,
    Germany

    Active - Recruiting

  • Heinrich Heine University, Dept of Neurosurgery, Universitätsklinik Düsseldorf

    Düsseldorf, 40225
    Germany

    Active - Recruiting

  • Universitätsklinikum Essen

    Essen,
    Germany

    Active - Recruiting

  • Freiburg University Hospital

    Freiburg,
    Germany

    Active - Recruiting

  • Katharinenhospital - Neurochirurgische Klinik Stuttgart

    Stuttgart,
    Germany

    Active - Recruiting

  • Hospital12 de Octubre

    Madrid,
    Spain

    Site Not Available

  • Canton Hospital St. Gallen

    St. Gallen,
    Switzerland

    Active - Recruiting

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