Actively Recruiting
Bactiseal Catheter Safety Registry Study
Led by Integra LifeSciences Corporation · Updated on 2025-01-27
200
Participants Needed
8
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Bactiseal Catheter Safety Registry Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The Ethics Committee exempts informed consent or the subject or their legal representative signed the informed consent form before enrollment
- The subject has an indication suitable for using the Bactiseal catheter
- The subject had a hydrocephalus shunt catheter implanted for at least 2 years at enrollment
You will not qualify if you...
- The subject does not have an indication suitable for using the catheter
- The subject is allergic to any component of the catheter, including silicone, rifampicin, or clindamycin
- The subject had an infection at the implant site (such as ventriculitis, meningitis, peritonitis, or skin infection) when the shunt was implanted
- The subject was implanted simultaneously with another shunt catheter different from the Bactiseal catheter
- The subject has contraindications for shunt operation
- The subject has uncorrected coagulopathy or any bleeding disorder
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100053
Completed
2
Beijing Hospital
Beijing, Beijing Municipality, China, 100730
Completed
3
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510280
Completed
4
the 2nd Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Actively Recruiting
5
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
Completed
6
the Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China, 430071
Actively Recruiting
7
Shanghai Children's Medical Center affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China, 200127
Actively Recruiting
8
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
Research Team
H
Hua Tang, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here