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RecruitingNCT06276543Updated Jan 27, 2025

Bactiseal Catheter Safety Registry Study

An observational study in Hydrocephalus, sponsored by Integra LifeSciences Corporation. Recruiting at 8 sites in China. Per ClinicalTrials.gov, last updated 2025-01-27.

Sponsored by Integra LifeSciences Corporation · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
200
Sex
All
01

Study summary

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)
02

Conditions studied

  • Hydrocephalus

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Keywords

  • hydrocephalus
  • cerebrospinal fluid
  • Shunt
  • antibiotic-impregnated catheter
  • infection
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

A total of 200 hydrocephalus patients will be enrolled and adverse events will be collected for those enrolled subjects within two years after the implantation of the Bactiseal catheter from January 01, 2019 to June 30, 2022, through reviewing subject record or hospital database.

Inclusion criteria

  1. The informed consent is exempted by the Ethics Committee of a research center. Or a subject or his/her legal representative signed the informed consent form (ICF) prior to the enrollment.
  2. A subject had an indication suitable to use Bactiseal Catheter.
  3. A subject implanted hydrocephalus shunt catheter for at least 2 years at the time of enrollment.

Exclusion criteria

Exclusion Criteria:

  1. A subject didn't have an indication suitable to use the catheter.
  2. A subject was known to be allergic to a component or ingredient of the catheter to be implanted, including silicone catheter, rifampicin, and clindamycin.
  3. According to the comprehensive judgment of an investigator, a subject had an infection of the implant site when the shunt is implanted, such as ventriculitis, meningitis, peritonitis, and local implant skin infection.
  4. A subject was simultaneously implanted with another shunt catheter different from Bactiseal Catheter.
  5. A subject had a contraindication of the shunt operation.
  6. A subject had uncorrected coagulopathy or any bleeding disorder.
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • antibiotic-impregnated catheter group

    Hydrocephalus patients implanted with antibiotic-impregnated catheter.

    Device: antibiotic-impregnated catheter

Interventions

  • Deviceantibiotic-impregnated catheter

    Hydrocephalus patient implant with antibiotic-impregnated catheter to shunt their cerebrospinal fluid.

05

What researchers measure

Primary outcomes

  1. Infection outcome

    Incidence of Bactiseal Shunt catheter related infection within 2 years post implant.

    Time frame: 2 years post catheter implanted.

  2. Safety outcome

    Incidence of adverse events of a subject within 2 years post implant Bactiseal

    Time frame: 2 years post catheter implanted.

06

Study locations

4 of 8 sites recruiting
  • Xuanwu Hospital, Capital Medical University
    Beijing, Beijing 100053, China
    Completed
  • Beijing Hospital
    Beijing, Beijing 100730, China
    Completed
  • Zhujiang Hospital of Southern Medical University
    Guangzhou, Guangdong 510280, 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 430030, China
    Completed
  • the Zhongnan Hospital of Wuhan University
    Wuhan, Hubei 430071, China
    • Jingcao Chen, MD · Contact · 027-67812888
    Recruiting
  • Shanghai Children's Medical Center affiliated to Shanghai Jiaotong University School of Medicine
    Shanghai, Shanghai 200127, China
    Recruiting
  • West China Hospital of Sichuan University
    Chengdu, Sichuan 610041, China
    • Jianguo Xu, MD · Contact · 0086 28 85422114
    Recruiting
07

References and documents

Individual participant data

Plan to share: No — individual participant data (IPD) is not available to other researchers.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06276543
Lead sponsor
Integra LifeSciences Corporation
Responsible party
Sponsor
First posted
Feb 26, 2024
Start date
Sep 29, 2024
Primary completion
Jul 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Jan 27, 2025

Study contacts

Hua Tang, MD
Contact
hua.tang@integralife.com
0086 21-63179772 ext. 8108
Nan Bao, MD
principal investigator · Shanghai Children's Medical Center Affiliated to Shanghai Jiaotong University School of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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