Bactiseal Catheter Safety Registry in China

A Multi-center, Retrospective Registry Study on the Safety of Bactiseal Catheter

Research Purpose: This study aimed to continue to evaluate safety information from subjects implanted with a catheter (trade name: Bactiseal) produced by Codman & Shurtleff, Inc. of the United States. Device safety would be assessed based on all the adverse events that occurred within one year after the subjects implanted the catheter.

Study Overview

• Status: Completed
• Conditions: Hydrocephalus
• Intervention / Treatment: Device: Bactiseal Catheter

Detailed Description

This study aimed to continue to evaluate safety information from subjects implanted with a catheter (trade name: Bactiseal) produced by Codman & Shurtleff, Inc. of the United States. Device safety would be assessed based on all the adverse events that occurred within one year after the subjects implanted the catheter.

This study was designed to be single arm, multi-center, and retrospective. A total of 50 patients would be retrospectively enrolled. Information would be collected on adverse events of subjects enrolled within one year after the implantation of the Bactiseal Catheter from August 07, 2018 to Novemver 30, 2020.

The following information would be collected from subjects' medical records or hospitals' databases (if any):

1. General condition of the subjects
2. Intraoperative condition and catheter implantation
3. Information on the shunt product
4. Adverse events of subjects within one year after the operation and classification of the adverse events
5. Relevant examinations in case of postoperative infection
6. Other adverse event-related information (except anticipated adverse events)

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100045
      • Beijing Children's Hospital, Capital Medical University
    • Beijing, Beijing, China, 100730
      • Beijing Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200127
      • Shanghai Children's Medical Center affiliated to Shanghai Jiaotong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects had an indication suitable to use Bactiseal Catheter and have received a hydrocephalus shunt at least one year ago.

Description

Inclusion Criteria:

• The informed consent was exempted by the Ethics Committee of a research center. Either a subject or his/her legal representative signed the informed consent form (ICF) prior to enrollment.
• A subject had an indication suitable to use Bactiseal Catheter.
• A subject received a hydrocephalus shunt at least one year ago.

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
50 Participants With Non-infection Within One Year	50 Participants with Non-infection Within One Year	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Type and Incidence of Adverse Events of 50 Subjects Within One Year	Type and incidence of adverse events of 50 subjects within one year after catheter implanted	1 year

Collaborators and Investigators

• Sponsor: Integra LifeSciences Corporation

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): November 30, 2020
• Study Completion (Actual): November 30, 2020

Study Registration Dates

• First Submitted: July 29, 2020
• First Submitted That Met QC Criteria: July 29, 2020
• First Posted (Actual): August 3, 2020

Study Record Updates

• Last Update Posted (Actual): March 28, 2023
• Last Update Submitted That Met QC Criteria: February 28, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: infection; hydrocephalus shunt
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hydrocephalus
• Other Study ID Numbers: C-BSEAL-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No