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 @ 3:48 PM
Ignite Modification Date:
2025-12-24 @ 3:48 PM
NCT ID:
NCT00197392
Eligibility Criteria:
Inclusion Criteria:
* The Subject is 18 years or older.
* The Subject (family member/legal representative) has given written Informed Consent prior to enrollment into this trial OR, where the Subject is unable to consent and no relative/legal representative is available to offer consent, appropriate legal and ethical practices are employed and thoroughly documented according to the laws and policies of the respective country and institution.
* The Subject (family member/legal representative) is willing to participate in this trial for the duration of the implanted EVD system and is willing to comply with the protocol requirements.
Exclusion Criteria:
* Within the preceding 30 days, the Subject has enrolled or participated in another trial utilizing an anti-microbial drug or medical device implanted in or directly influencing the CNS and/or spinal cord.
* The Subject is pregnant or lactating.
* The Subject has a suspected or documented allergy to the materials of the EVD system, including silicone, rifampin and clindamycin.
* The Subject has a positive CSF culture prior to EVD implant.
* The Subject is immunocompromised.
* The Subject requires more than one ventricular catheter concurrently.
* The Subject has had an EVD catheter within the previous 30 days.
* The Subject has sepsis, ventriculitis, meningitis, a skin infection/inflammation at or near the implantation site, an ear infection on either side, or a severe respiratory tract infection that, in the opinion of the Investigator, would most likely compromise the effectiveness of the EVD system.
* The Subject is known to have received systemic antibiotic therapy within a 14-day period preceding screening for inclusion in this trial.
* The Subject has an uncontrolled coagulopathy or any other known bleeding diathesis.
* The Subject is otherwise determined by the Investigator to be medically unsuitable for participation in this trial.
* The Subject is a prisoner.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00197392
Study Brief:
Protocol Section:
NCT00197392