MedTrace Logo

Bactiseal Catheter Safety Registry in China

NCT04496414 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2023-03-28

Study results available
· View outcomes & findings →

Summary

Research Purpose: This study aimed to continue to evaluate safety information from subjects implanted with a catheter (trade name: Bactiseal) produced by Codman \& Shurtleff, Inc. of the United States. Device safety would be assessed based on all the adverse events that occurred within one year after the subjects implanted the catheter.

Conditions

  • Hydrocephalus

Interventions

DEVICE

Bactiseal Catheter

Bactiseal Catheter manufactured by Codman \& Shurtleff, Inc. in the United States is a silicon catheter impregnated in rifampicin and clindamycin.

Sponsors & Collaborators

  • Integra LifeSciences Corporation

    lead INDUSTRY

Principal Investigators

  • Hua Tang, MD · Integra Life Sciences

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2020-11-30
Completion
2020-11-30

Countries

  • China

Study Locations

More Related Trials

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 NCT04496414 on ClinicalTrials.gov