protocolSection identificationModule nctId: NCT06276543, orgStudyIdInfo id: C-BSEAL-002, briefTitle: Bactiseal Catheter Safety Registry Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2026-07-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Integra LifeSciences Corporation, class: INDUSTRY, descriptionModule briefSummary: 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 implantation3. Information on the shunt catheters4. 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), conditionsModule conditions: Hydrocephalus, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: antibiotic-impregnated catheter, outcomesModule primaryOutcomes measure: Infection outcome, primaryOutcomes measure: Safety outcome, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing Children's Hospital, Capital Medical University, city: Beijing, state: Beijing, zip: 100045, country: China, contacts name: Hailang Sun, MD, role: CONTACT, phone: 0086-10-59616408, email: et2007yy@163.com, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Xuanwu Hospital, Capital Medical University, city: Beijing, state: Beijing, zip: 100053, country: China, contacts name: Ning Wang, MD, role: CONTACT, phone: 010-83198899, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Beijing Hospital, city: Beijing, state: Beijing, zip: 100730, country: China, contacts name: Cheng Sha, MD, role: CONTACT, phone: 0086-10-85132266, email: bjshacheng@163.com, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Guangzhou Women and Children Medical Center, city: Guangzhou, state: Guangdong, zip: 510623, country: China, contacts name: Fangcheng Li, MD, role: CONTACT, phone: 020-81886332, geoPoint lat: 23.11667, lon: 113.25, locations facility: Guangdong Province People Hospital, city: Guangzhou, state: Guangdong, zip: 519041, country: China, contacts name: Feng Wang, MD, role: CONTACT, phone: 0086 20 83827812, geoPoint lat: 23.11667, lon: 113.25, locations facility: Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology, city: Wuhan, state: Hubei, zip: 430030, country: China, contacts name: Ting Lei, MD, role: CONTACT, phone: 0086 27 83662688, geoPoint lat: 30.58333, lon: 114.26667, locations facility: Shanghai Children's Medical Center affiliated to Shanghai Jiaotong University School of Medicine, city: Shanghai, state: Shanghai, zip: 200127, country: China, contacts name: Nan Bao, MD, role: CONTACT, phone: 0086-21-38626161, email: baonan@scmc.com.cn, geoPoint lat: 31.22222, lon: 121.45806, locations facility: West China Hospital of Sichuan University, city: Chengdu, state: Sichuan, zip: 610041, country: China, contacts name: Jianguo Xu, MD, role: CONTACT, phone: 0086 28 85422114, geoPoint lat: 30.66667, lon: 104.06667, hasResults: False