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Bactiseal Catheter Safety Registry Study

NCT06276543 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2025-01-27

No results posted yet for this study

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 safety will be assessed based on all the adverse events that occurred within 2 years after implanted the catheter.

Research Design:

This study is designed to be single arm, multi-center, and retrospective. A total of 200 subjects will be retrospectively enrolled. Information will be collected on adverse events, including bacterial culture and drug resistance testing when infection (if done), of subjects enrolled within 2 years after the implantation of the Bactiseal Catheter between January 01, 2019 and June 30, 2022.

The following information will be collected from subjects' medical records or hospitals' databases (if any):

1. General condition of the subjects (including previous shunting and external drainage operation)
2. Intraoperative condition and catheter implantation
3. Information on the shunt catheters
4. Adverse events of subjects within 2 years after the operation and classification of the adverse events (except anticipated adverse events listed in section 8.1.2)
5. Relevant examinations in case of postoperative infection, including bacterial culture and drug resistance testing (if done)

Conditions

  • Hydrocephalus

Interventions

DEVICE

antibiotic-impregnated catheter

Hydrocephalus patient implant with antibiotic-impregnated catheter to shunt their cerebrospinal fluid.

Sponsors & Collaborators

  • Integra LifeSciences Corporation

    lead INDUSTRY

Principal Investigators

  • Nan Bao, MD · Shanghai Children's Medical Center Affiliated to Shanghai Jiaotong University School of Medicine

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-29
Primary Completion
2026-07-31
Completion
2026-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06276543 on ClinicalTrials.gov