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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04496414
Other study ID # C-BSEAL-001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2020
Est. completion date November 30, 2020

Study information

Verified date February 2023
Source Integra LifeSciences Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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)


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date November 30, 2020
Est. primary completion date November 30, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Bactiseal Catheter
Bactiseal Catheter manufactured by Codman & Shurtleff, Inc. in the United States is a silicon catheter impregnated in rifampicin and clindamycin.

Locations

Country Name City State
China Beijing Children's Hospital, Capital Medical University Beijing Beijing
China Beijing Hospital Beijing Beijing
China Shanghai Children's Medical Center affiliated to Shanghai Jiaotong University School of Medicine Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Integra LifeSciences Corporation

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 50 Participants With Non-infection Within One Year 50 Participants with Non-infection Within One Year 1 year
Secondary 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
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