Bactiseal Catheter Safety Registry in China

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Brief Title

Bactiseal Catheter Safety Registry in China

Official Title

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

Brief Summary

      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.
    

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 [Patient Registry]


Primary Outcome

50 Participants With Non-infection Within One Year

Secondary Outcome

 Type and Incidence of Adverse Events of 50 Subjects Within One Year

Condition

Hydrocephalus

Intervention

Bactiseal Catheter


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

50

Start Date

September 1, 2020

Completion Date

November 30, 2020

Primary Completion Date

November 30, 2020

Eligibility Criteria

        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.
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Hua Tang, MD, , 

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT04496414

Organization ID

C-BSEAL-001


Responsible Party

Sponsor

Study Sponsor

Integra LifeSciences Corporation


Study Sponsor

Hua Tang, MD, Study Director, Integra Life Sciences


Verification Date

August 2022