HydrocephalusNCT04496414
Bactiseal Catheter Safety Registry in China
An observational study of Hydrocephalus, run by Integra LifeSciences Corporation at 3 sites in China.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hydrocephalus
- What is being tested?
- Bactiseal Catheter
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 3 sitesChina
- Study dates
- 1 Sep 2020to 30 Nov 2020
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: Subjects had an indication suitable to use Bactiseal Catheter and have received a hydrocephalus shunt at least one year ago.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Beijing Children's Hospital, Capital Medical University
Beijing, Beijing Municipality, 100045
Beijing Hospital
Beijing, Beijing Municipality, 100730
Shanghai Children's Medical Center affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200127
About this study
Official title: A Multi-center, Retrospective Registry Study on the Safety of Bactiseal Catheter
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.
Read the detailed 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):
- General condition of the subjects
- Intraoperative condition and catheter implantation
- Information on the shunt product
- Adverse events of subjects within one year after the operation and classification of the adverse events
- Relevant examinations in case of postoperative infection
- Other adverse event-related information (except anticipated adverse events)
- Conditions
- Hydrocephalus
- Being tested
- Bactiseal Catheter
- Keywords
- hydrocephalus shunt, 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.
Bactiseal CatheterDevice
Bactiseal Catheter manufactured by Codman \& Shurtleff, Inc. in the United States is a silicon catheter impregnated in rifampicin and clindamycin.
What is being measured
The primary outcome is the main question the study is designed to answer.
50 Participants With Non-infection Within One Year
50 Participants with Non-infection Within One Year
Measured: 1 year
Secondary outcomes (1)
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2020
- Study start1 Sep 2020
- Primary completion30 Nov 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Other
- Enrolment
- 50 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Integra LifeSciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hua Tang, MD, Study director, Integra Life Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04496414
- Sponsor's protocol ID
- C-BSEAL-001
- Status last verified
- Feb 2023
- First submitted
- 29 Jul 2020
- Last updated
- 28 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. 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
- NCT04496414
- Acronym / sponsor ID
- C-BSEAL-001
- Conditions
- Hydrocephalus
- Keywords
- hydrocephalus shunt, infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Integra LifeSciences CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 3 Aug 2020 (actual)
- Results
- Posted 21 Dec 2021
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 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.
Detailed 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):
- General condition of the subjects
- Intraoperative condition and catheter implantation
- Information on the shunt product
- Adverse events of subjects within one year after the operation and classification of the adverse events
- Relevant examinations in case of postoperative infection
- Other adverse event-related information (except anticipated adverse events)
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects had an indication suitable to use Bactiseal Catheter and have received a hydrocephalus shunt at least one year ago.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| Bactiseal CatheterBactiseal Catheter manufactured by Codman \& Shurtleff, Inc. in the United States is a silicon catheter impregnated in rifampicin and clindamycin. | Device | – |
Primary outcome
50 Participants With Non-infection Within One Year
Time frame: 1 year
50 Participants with Non-infection Within One Year
1 secondary outcome
Type and Incidence of Adverse Events of 50 Subjects Within One Year
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Hua Tang, MD study director
Integra Life Sciences
3 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 3 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: finished, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Yes. Results are posted in the registry (first posted 21 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
50 Participants With Non-infection Within One Year (time frame: 1 year). 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 28 Mar 2023.