Actively Recruiting
A Multi-center, Retrospective Registry Study on the Safety of Bactiseal Catheter for Hydrocephalus Patients
Led by Integra LifeSciences Corporation · Updated on 2025-01-27
200
Participants Needed
8
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a multi-center, retrospective study to continuously evaluate the safety of the Bactiseal catheter, an antibiotic-impregnated device used in patients with hydrocephalus. The study focuses on monitoring adverse events, including infections, that occur within two years after catheter implantation. It aims to collect data from medical records on the general and intraoperative conditions of patients and the catheter's performance. The study involves hydrocephalus patients who have had the Bactiseal catheter implanted to shunt cerebrospinal fluid. This single-arm study will retrospectively enroll 200 subjects who received the catheter between January 1, 2019, and June 30, 2022. Data collected includes adverse events, bacterial cultures, and drug resistance tests if infections occurred. Participants' medical information will be reviewed for up to two years following catheter implantation. Researchers will assess safety outcomes and infections related to the catheter. Information on previous surgeries, catheter details, and postoperative complications will be gathered to better understand the device's safety. The study does not involve additional interventions or visits, as it is based on existing medical records.
CONDITIONS
Brief Title
Bactiseal Catheter Safety Registry Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The informed consent is exempted by the Ethics Committee of a research center or a subject or legal representative signed the informed consent form prior to enrollment.
- A subject had an indication suitable to use Bactiseal Catheter.
- A subject implanted hydrocephalus shunt catheter for at least 2 years at the time of enrollment.
You will not qualify if you...
- A subject didn't have an indication suitable to use the catheter.
- A subject was allergic to components of the catheter, including silicone, rifampicin, or clindamycin.
- A subject had an infection at the implant site when the shunt was implanted, such as ventriculitis, meningitis, peritonitis, or local implant skin infection.
- A subject was implanted simultaneously with another shunt catheter different from Bactiseal Catheter.
- A subject had a contraindication for the shunt operation.
- A subject had uncorrected coagulopathy or any bleeding disorder.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 years
Participants who have been implanted with the antibiotic-impregnated catheter are observed for safety and infection outcomes.
Visits as per routine clinical follow-up
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
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
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