NCT06276543

Bactiseal Catheter Safety Registry Study

A Multi-center, Retrospective Registry Study on the Safety of Bactiseal Catheter

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Integra LifeSciences Corporation · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Type	Name	Description
DEVICE	antibiotic-impregnated catheter	Hydrocephalus patient implant with antibiotic-impregnated catheter to shunt their cerebrospinal fluid.

Timeline

• Start date: 2024-09-29
• Primary completion: 2026-07-31
• Completion: 2026-12-31
• First posted: 2024-02-26
• Last updated: 2025-01-27

Locations

8 sites across 1 country: China