Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-24 @ 9:07 PM
NCT ID:
NCT00280904
Eligibility Criteria:
Inclusion Criteria:
* The Subject requires a surgical procedure to implant (de novo) a ventriculoperitoneal shunt or to replace an already implanted shunt catheter for the treatment of hydrocephalus.
* The Subject (family member/legal representative) has completed the Informed Consent process prior to enrollment into this Registry.
* The Subject (family member/legal representative) is willing to comply with the Registry protocol timelines \& requirements.
Exclusion Criteria:
* The Subject's planned shunt has distal drainage to the heart.
* The Subject has an active infection of the indwelling shunt system, cerebrospinal fluid or abdominal cavity.
* The Subject has ventriculitis, peritonitis or meningitis.
* The Subject has sepsis.
* The Subject has a history of poor wound healing.
* The Subject 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 Registry.
* The Subject has had any form of bowel surgery 30 days prior to device implant or anticipates bowel surgery within 90 days following device implant
* The Subject has loculation(s) within the ventricular system.
* The Subject is otherwise determined by the Investigator to be medically unsuitable for participation in this Registry.
* The Subject is currently enrolled in another drug or device trial or has been previously entered in this trial.
* The Subject exhibits other difficulties, which would preclude follow-up for 90 days.
* The Subject is a prisoner.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00280904
Study Brief:
Protocol Section:
NCT00280904