Active — Not RecruitingNot Applicable

Post Market Clinical Follow-up of CODMAN CERTAS Programmable Valve

Belgium, Germany160 participantsStarted 2023-01-24

Plain-language summary

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

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Patient and/or legally authorized representative has agreed to participate in the study by signing the EC-approved consent form, where applicable.
✓. Patients (of any age) who underwent or who plan to have a surgical procedure utilizing one of the Codman CERTAS Plus Programmable Valves.
✓. Patient (legally designated representative) is willing to comply with the study protocol timelines \& requirements.
✓. 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.

✕. Patients undergoing implantation of the CODMAN CERTAS Plus Programmable Valve as a revision procedure.
✕. Patient's planned shunt has distal drainage to the heart.
✕. Patient has ventriculitis, peritonitis or meningitis.
✕. Patient has sepsis.
✕. Patient has a history of poor wound healing.
✕. 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.
✕. Patient has had any form of bowel surgery 30 days prior to device implant or anticipates bowel surgery within 90 days following device implant.
✕. Patient is otherwise determined by the Investigator to be medically unsuitable for participation in this study.

Precise Device Placement: Maintaining Integrity and Functionality at 30 Days Post-Deployment

Timeframe: 30 Days

NCT IDNCT05397106

SponsorIntegra LifeSciences Corporation

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2029-01-24

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Patient and/or legally authorized representative has agreed to participate in the study by signing the EC-approved consent form, where applicable.
✓. Patients (of any age) who underwent or who plan to have a surgical procedure utilizing one of the Codman CERTAS Plus Programmable Valves.
✓. Patient (legally designated representative) is willing to comply with the study protocol timelines \& requirements.
✓. 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.

✕. Patients undergoing implantation of the CODMAN CERTAS Plus Programmable Valve as a revision procedure.
✕. Patient's planned shunt has distal drainage to the heart.
✕. Patient has ventriculitis, peritonitis or meningitis.
✕. Patient has sepsis.
✕. Patient has a history of poor wound healing.
✕. 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.
✕. Patient has had any form of bowel surgery 30 days prior to device implant or anticipates bowel surgery within 90 days following device implant.
✕. Patient is otherwise determined by the Investigator to be medically unsuitable for participation in this study.