Status:

RECRUITING

Bactiseal Catheter Safety Registry Study

Lead Sponsor:

Integra LifeSciences Corporation

Conditions:

Hydrocephalus

Eligibility:

All Genders

Brief Summary

Research Purpose: This study aims to continuously evaluate the safety of subjects implanted with a catheter (trade name: Bactiseal) produced by Integra LifeSciences Production Corporation. Device saf...

Eligibility Criteria

Inclusion Criteria:

  1. The informed consent is exempted by the Ethics Committee of a research center. Or a subject or his/her legal representative signed the informed consent form (ICF) prior to the enrollment.
  2. A subject had an indication suitable to use Bactiseal Catheter.
  3. A subject implanted hydrocephalus shunt catheter for at least 2 years at the time of enrollment.

Exclusion Criteria:

  1. A subject didn't have an indication suitable to use the catheter.
  2. A subject was known to be allergic to a component or ingredient of the catheter to be implanted, including silicone catheter, rifampicin, and clindamycin.
  3. According to the comprehensive judgment of an investigator, a subject had an infection of the implant site when the shunt is implanted, such as ventriculitis, meningitis, peritonitis, and local implant skin infection.
  4. A subject was simultaneously implanted with another shunt catheter different from Bactiseal Catheter.
  5. A subject had a contraindication of the shunt operation.
  6. A subject had uncorrected coagulopathy or any bleeding disorder.

Key Trial Info

Start Date :

September 29 2024

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 31 2026

Estimated Enrollment :

200 Patients enrolled

Trial Details

Trial ID

NCT06276543

Start Date

September 29 2024

End Date

December 31 2026

Last Update

January 27 2025

Active Locations (8)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 2 (8 locations)

1

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, China, 100053

2

Beijing Hospital

Beijing, Beijing Municipality, China, 100730

3

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China, 510280

4

the 2nd Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China