HydrocephalusNCT06276543
Bactiseal Catheter Safety Registry Study
An observational study of Hydrocephalus, run by Integra LifeSciences Corporation at 8 sites in China.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hydrocephalus
- What is being tested?
- antibiotic-impregnated catheter
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 8 sitesChina
- Study dates
- 29 Sep 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
China8 sites, 4 recruiting
- Completed
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100053
- Completed
Beijing Hospital
Beijing, Beijing Municipality, 100730
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Jianguo Xu, MD, 0086 28 85422114
- Completed
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510280
- Recruiting
the 2nd Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang
Jinquan Cai, MD, +86 0451 86605612, caijinquan666777@126.com
- Recruiting
Shanghai Children's Medical Center affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200127
Nan Bao, MD, 0086-21-38626161, baonan@scmc.com.cn
- Completed
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
- Recruiting
the Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071
Jingcao Chen, MD, 027-67812888
About this study
Official title: A Multi-center, Retrospective Registry Study on the Safety of Bactiseal Catheter
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.
Read more
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):
- General condition of the subjects (including previous shunting and external drainage operation)
- Intraoperative condition and catheter implantation
- Information on the shunt catheters
- 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)
- Relevant examinations in case of postoperative infection, including bacterial culture and drug resistance testing (if done)
- Conditions
- Hydrocephalus
- Being tested
- antibiotic-impregnated catheter
- Keywords
- hydrocephalus, cerebrospinal fluid, Shunt, antibiotic-impregnated catheter, infection
- Medical subject headings
- Hydrocephalus, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antibiotic-impregnated catheterDevice
Hydrocephalus patient implant with antibiotic-impregnated catheter to shunt their cerebrospinal fluid.
| Study group | Role | What they receive |
|---|---|---|
| antibiotic-impregnated catheter group | Hydrocephalus patients implanted with antibiotic-impregnated catheter. Receives: Device: antibiotic-impregnated catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infection outcome
Incidence of Bactiseal Shunt catheter related infection within 2 years post implant.
Measured: 2 years post catheter implanted.
Safety outcome
Incidence of adverse events of a subject within 2 years post implant Bactiseal
Measured: 2 years post catheter implanted.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start29 Sep 2024
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HydrocephalusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Integra LifeSciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nan Bao, MD, Principal investigator, Shanghai Children's Medical Center Affiliated to Shanghai Jiaotong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06276543
- Sponsor's protocol ID
- C-BSEAL-002
- Status last verified
- Jan 2025
- First submitted
- 8 Feb 2024
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: individual participant data (IPD) is not available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Retrospective Registry Study on the Safety of Bactiseal Catheter
- ClinicalTrials.gov ID
- NCT06276543
- Acronym / sponsor ID
- C-BSEAL-002
- Conditions
- Hydrocephalus
- Keywords
- hydrocephalus, cerebrospinal fluid, Shunt, antibiotic-impregnated catheter, infection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Integra LifeSciences CorporationIndustry (pharma, biotech, devices)
- Study start
- 29 Sep 2024 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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):
- General condition of the subjects (including previous shunting and external drainage operation)
- Intraoperative condition and catheter implantation
- Information on the shunt catheters
- 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)
- Relevant examinations in case of postoperative infection, including bacterial culture and drug resistance testing (if done)
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| antibiotic-impregnated catheter group | – | Device: antibiotic-impregnated catheterHydrocephalus patients implanted with antibiotic-impregnated catheter. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| antibiotic-impregnated catheterHydrocephalus patient implant with antibiotic-impregnated catheter to shunt their cerebrospinal fluid. | Device | antibiotic-impregnated catheter group |
Primary outcome
Infection outcome
Time frame: 2 years post catheter implanted.
Incidence of Bactiseal Shunt catheter related infection within 2 years post implant.
Safety outcome
Time frame: 2 years post catheter implanted.
Incidence of adverse events of a subject within 2 years post implant Bactiseal
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
- Individual participant dataSharing planned: No. individual participant data (IPD) is not available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nan Bao, MD principal investigator
Shanghai Children's Medical Center Affiliated to Shanghai Jiaotong University School of Medicine
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hydrocephalus, run by Integra LifeSciences Corporation at 8 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hua Tang, MD (0086 21-63179772 ext. 8108, hua.tang@integralife.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infection outcome (time frame: 2 years post catheter implanted.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025.