Bactiseal Catheter Safety Registry in China

• Sponsor: Integra LifeSciences Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04496414
• Collaborator: (none)
• Enrollment: 50
• Locations: 3
• Actual Duration (Months): 3
• Patients Per Site: 16.7
• Patients Per Site Per Month: 5.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hydrocephalus	Device: Bactiseal 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):

1. General condition of the subjects

2. Intraoperative condition and catheter implantation

3. Information on the shunt product

4. Adverse events of subjects within one year after the operation and classification of the adverse events

5. Relevant examinations in case of postoperative infection

6. Other adverse event-related information (except anticipated adverse events)

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Other
• Official Title: A Multi-center, Retrospective Registry Study on the Safety of Bactiseal Catheter
• Actual Study Start Date: Sep 1, 2020
• Actual Primary Completion Date: Nov 30, 2020
• Actual Study Completion Date: Nov 30, 2020

Outcome Measures

Primary Outcome Measures

1. 50 Participants With Non-infection Within One Year [1 year]

   50 Participants with Non-infection Within One Year

Secondary Outcome Measures

1. Type and Incidence of Adverse Events of 50 Subjects Within One Year [1 year]

   Type and incidence of adverse events of 50 subjects within one year after catheter implanted

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Children's Hospital, Capital Medical University	Beijing	Beijing	China	100045
2	Beijing Hospital	Beijing	Beijing	China	100730
3	Shanghai Children's Medical Center affiliated to Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai	China	200127

Sponsors and Collaborators

• Integra LifeSciences Corporation

Investigators

• Study Director: Hua Tang, MD, Integra Life Sciences

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 18, 2019

More Information

Publications

None provided.

• Responsible Party: Integra LifeSciences Corporation
• ClinicalTrials.gov Identifier: NCT04496414
• Other Study ID Numbers: C-BSEAL-001
• First Posted: Aug 3, 2020
• Last Update Posted: Mar 4, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Integra LifeSciences Corporation: hydrocephalus shunt; infection
• Additional relevant MeSH terms: Hydrocephalus

Study Results

Participant Flow

Recruitment Details	The study was conducted in Shanghai Children's Medical Center, School of Medicine, Shanghai Jiao Tong University, Beijing Children Hospital, Capital Medical University, Beijing Hospital. The first subject was enrolled in Sep 1, 2020, and last subject was enrolled in Nov 16, 2020.
Pre-assignment Detail	Screened 62 patients, 50 of them were enrolled, including 7 adult patients and 43 minors (subject age below 18). 12 patients were screening failures for not meeting inclusion/exclusion criteria and without post operation follow up.

Arm/Group Title	Bactiseal Catheter Arm
Arm/Group Description	Hydrocephalus subjects implanted with a Bactiseal catheter for one year.
Period Title: Overall Study
STARTED	50
COMPLETED	50
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Bactiseal Catheter Arm
Arm/Group Description	Hydrocephalus subjects implanted with a Bactiseal catheter for one year.
Overall Participants	50
Age (Count of Participants)
<=18 years	43 86%
Between 18 and 65 years	7 14%
>=65 years	0 0%
Age (year) [Mean (Full Range) ]
Mean (Full Range) [year]	9.38
Sex: Female, Male (Count of Participants)
Female	19 38%
Male	31 62%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	50 100%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
China	50 100%

Outcome Measures

1. Primary Outcome

Title	50 Participants With Non-infection Within One Year
Description	50 Participants with Non-infection Within One Year
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

50 participants implanted Bactiseal Catheter for 1 year

Arm/Group Title	Bactiseal Catheter Arm
Arm/Group Description	Hydrocephalus subjects implanted with a Bactiseal catheter for one year.
Measure Participants	50
Count of Participants [Participants]	1 2%

2. Secondary Outcome

Title	Type and Incidence of Adverse Events of 50 Subjects Within One Year
Description	Type and incidence of adverse events of 50 subjects within one year after catheter implanted
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	within 1 year after investigated device implanted
Arm/Group Title	Bactiseal Catheter Arm
Arm/Group Description	Hydrocephalus subjects implanted with a Bactiseal catheter for one year.
All Cause Mortality
	Bactiseal Catheter Arm
	Affected / at Risk (%)	# Events
Total	1/50 (2%)
Serious Adverse Events
	Bactiseal Catheter Arm
	Affected / at Risk (%)	# Events
Total	13/50 (26%)
Infections and infestations
Infectious pneumonia	1/50 (2%)	1
Urinary tract infection	1/50 (2%)	1
Gastroenteritis	1/50 (2%)	1
Investigations
shunt device disorder	1/50 (2%)	1
shunt device occlusion	1/50 (2%)	1
shunt blockage	1/50 (2%)	1
Metabolism and nutrition disorders
Electrolyte disorders	1/50 (2%)	1
Nervous system disorders
cerebral hemorrhage	2/50 (4%)	2
subdural hematoma	2/50 (4%)	2
intracranial infection	1/50 (2%)	1
Cerebrospinal fluid leakage	1/50 (2%)	1
Demyelination	1/50 (2%)	1
Infantile spasms	1/50 (2%)	1
Epilepsia	1/50 (2%)	1
Other (Not Including Serious) Adverse Events
	Bactiseal Catheter Arm
	Affected / at Risk (%)	# Events
Total	30/50 (60%)
Gastrointestinal disorders
diarrhea	8/50 (16%)	8
Infections and infestations
fever	5/50 (10%)	5
Nervous system disorders
Cerebral hemorrhage	2/50 (4%)	2
Subdural hematoma	2/50 (4%)	2
Epilepsia	2/50 (4%)	2
Respiratory, thoracic and mediastinal disorders
respiratory infection	6/50 (12%)	6
Upper respiratory tract infection	4/50 (8%)	4
Pneumonia	2/50 (4%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.