Bactiseal Catheter Safety Registry Study

Hydrocephalus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06276543
• Other study ID #: C-BSEAL-002
• Status: Not yet recruiting
• Start date: June 1, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2024
• Source: Integra LifeSciences Corporation
• Contact: Hua Tang, MD
• Phone: 0086 21-63179772
• Email: hua.tang[@]integralife.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 31, 2026
• Est. primary completion date: July 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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:

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.

Related Conditions & MeSH terms

• Hydrocephalus

Intervention

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

Locations

Country	Name	City	State
China	Beijing Children's Hospital, Capital Medical University	Beijing	Beijing
China	Beijing Hospital	Beijing	Beijing
China	Xuanwu Hospital, Capital Medical University	Beijing	Beijing
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	Guangdong Province People Hospital	Guangzhou	Guangdong
China	Guangzhou Women and Children Medical Center	Guangzhou	Guangdong
China	Shanghai Children's Medical Center affiliated to Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai
China	Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Integra LifeSciences Corporation

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infection outcome	Incidence of Bactiseal Shunt catheter related infection within 2 years post implant.	2 years post catheter implanted.
Primary	Safety outcome	Incidence of adverse events of a subject within 2 years post implant Bactiseal	2 years post catheter implanted.