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Post Market Clinical Follow-up of CODMAN CERTAS Programmable Valve

Sponsored by Integra LifeSciences Corporation

About this trial

Last updated 2 years ago

Study ID

C-CERTAS-002

Status

Recruiting

Type

Observational

Placebo

No

Accepting

18-75 Years
All
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Started 2 years ago

What is this trial about?

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

What are the participation requirements?

Yes

Inclusion Criteria

1. Patient requires a surgical procedure to implant (de novo) a shunt for the treatment of hydrocephalus utilizing CODMAN CERTAS Plus Programmable Valve according to it intended use.

2. Patient (legally designated representative) has completed the Informed Consent process prior to enrollment into this study.

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

No

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

Locations

Location

Status

Recruiting
Not yet recruiting
Active, not recruiting
Active, not recruiting