Bactiseal Catheter Safety Registry in China

Hydrocephalus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04496414
• Other study ID #: C-BSEAL-001
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Hydrocephalus

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