Condition: Hydrocephalus · Sponsor: Integra LifeSciences Corporation
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)
This description comes directly from the study's public registry record.
Hua Tang, MD · 0086 21-63179772 · hua.tang@integralife.com
Always discuss trial participation with your own doctor first.
| Xuanwu Hospital, Capital Medical University | Beijing, Beijing Municipality, China | Completed |
| Beijing Hospital | Beijing, Beijing Municipality, China | Completed |
| Zhujiang Hospital of Southern Medical University | Guangzhou, Guangdong, China | Completed |
| the 2nd Affiliated Hospital of Harbin Medical University | Harbin, Heilongjiang, China | Recruiting |
| Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology | Wuhan, Hubei, China | Completed |
| the Zhongnan Hospital of Wuhan University | Wuhan, Hubei, China | Recruiting |
| Shanghai Children's Medical Center affiliated to Shanghai Jiaotong University School of Medicine | Shanghai, Shanghai Municipality, China | Recruiting |
| West China Hospital of Sichuan University | Chengdu, Sichuan, China | Recruiting |
Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.
We email about this public record only. Unsubscribe anytime with one click. Never medical advice.
This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.
Source record: clinicaltrials.gov/study/NCT06276543