Bactiseal Catheter Safety Registry in China

NCT04496414 | Completed Results

• 1 other identifier: C-BSEAL-001
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 3

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.

Conditions

Hydrocephalus

Keywords

hydrocephalus shunt; infection

Outcome Measures

Primary Outcomes (1)

• 50 Participants With Non-infection Within One Year

  50 Participants with Non-infection Within One Year

  1 year

Secondary Outcomes (1)

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

  1 year

Interventions

Bactiseal Catheter DEVICE

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

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

Subjects had an indication suitable to use Bactiseal Catheter and have received a hydrocephalus shunt at least one year ago.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Integra LifeSciences Corporation: lead

Study Sites (3)

Beijing Children's Hospital, Capital Medical University

Beijing, Beijing Municipality, 100045, China

Location

Beijing Hospital

Beijing, Beijing Municipality, 100730, China

Location

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

Shanghai, Shanghai Municipality, 200127, China

Location

MeSH Terms

Conditions

Hydrocephalus; Infections

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Dr. Hua Tang
• Organization: Integra LifeSciences (Shanghai) Co., Ltd.

hua.tang@integralife.com

0086 21 63179772

Study Officials

• Hua Tang, MD

  Integra Life Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2020
• First Posted: August 3, 2020
• Study Start: September 1, 2020
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2020
• Last Updated: March 28, 2023
• Results First Posted: December 21, 2021

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)