Bactiseal Catheter Safety Registry Study

NCT06276543 | Recruiting

• 1 other identifier: C-BSEAL-002
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 8

Brief 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. 1.General condition of the subjects (including previous shunting and external drainage operation)
2. 2.Intraoperative condition and catheter implantation
3. 3.Information on the shunt catheters
4. 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. 5.Relevant examinations in case of postoperative infection, including bacterial culture and drug resistance testing (if done)

Conditions

Hydrocephalus

Keywords

hydrocephalus; cerebrospinal fluid; Shunt; antibiotic-impregnated catheter; infection

Outcome Measures

Primary Outcomes (2)

• Infection outcome

  Incidence of Bactiseal Shunt catheter related infection within 2 years post implant.

  2 years post catheter implanted.

• Safety outcome

  Incidence of adverse events of a subject within 2 years post implant Bactiseal

  2 years post catheter implanted.

Study Arms (1)

antibiotic-impregnated catheter group

Hydrocephalus patients implanted with antibiotic-impregnated catheter.

Device: antibiotic-impregnated catheter

Interventions

antibiotic-impregnated catheter DEVICE

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

antibiotic-impregnated catheter group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of 200 hydrocephalus patients will be enrolled and adverse events will be collected for those enrolled subjects within two years after the implantation of the Bactiseal catheter from January 01, 2019 to June 30, 2022, through reviewing subject record or hospital database.

You may qualify if:

• 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.
• A subject had an indication suitable to use Bactiseal Catheter.
• A subject implanted hydrocephalus shunt catheter for at least 2 years at the time of enrollment.

You may not qualify if:

• A subject didn't have an indication suitable to use the catheter.
• A subject was known to be allergic to a component or ingredient of the catheter to be implanted, including silicone catheter, rifampicin, and clindamycin.
• 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.
• A subject was simultaneously implanted with another shunt catheter different from Bactiseal Catheter.
• A subject had a contraindication of the shunt operation.
• A subject had uncorrected coagulopathy or any bleeding disorder.

Sponsors & Collaborators

• Integra LifeSciences Corporation: lead

Study Sites (8)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

COMPLETED

Beijing Hospital

Beijing, Beijing Municipality, 100730, China

COMPLETED

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510280, China

COMPLETED

the 2nd Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

RECRUITING

Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

COMPLETED

the Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China

RECRUITING

Shanghai Children's Medical Center affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Conditions

Hydrocephalus; Infections

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Nan Bao, MD

  Shanghai Children's Medical Center Affiliated to Shanghai Jiaotong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hua Tang, MD

CONTACT

0086 21-63179772; hua.tang@integralife.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2024
• First Posted: February 26, 2024
• Study Start: September 29, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (8)