Trial Outcomes & Findings for Bactiseal Catheter Safety Registry in China (NCT NCT04496414)
NCT ID: NCT04496414
Last Updated: 2023-03-28
Results Overview
50 Participants with Non-infection Within One Year
Recruitment status
COMPLETED
Target enrollment
50 participants
Primary outcome timeframe
1 year
Results posted on
2023-03-28
Participant Flow
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.
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.
Participant milestones
| Measure |
Bactiseal Catheter Arm
Hydrocephalus subjects implanted with a Bactiseal catheter for one year.
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bactiseal Catheter Safety Registry in China
Baseline characteristics by cohort
| Measure |
Bactiseal Catheter Arm
n=50 Participants
Hydrocephalus subjects implanted with a Bactiseal catheter for one year.
|
|---|---|
|
Age, Categorical
<=18 years
|
43 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
9.38 year
n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
50 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
50 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: 50 participants implanted Bactiseal Catheter for 1 year
50 Participants with Non-infection Within One Year
Outcome measures
| Measure |
Bactiseal Catheter Arm
n=50 Participants
Hydrocephalus subjects implanted with a Bactiseal catheter for one year.
|
|---|---|
|
50 Participants With Non-infection Within One Year
|
1 Participants
|
SECONDARY outcome
Timeframe: 1 yearType and incidence of adverse events of 50 subjects within one year after catheter implanted
Outcome measures
Outcome data not reported
Adverse Events
Bactiseal Catheter Arm
Serious events: 13 serious events
Other events: 30 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Bactiseal Catheter Arm
n=50 participants at risk
Hydrocephalus subjects implanted with a Bactiseal catheter for one year.
|
|---|---|
|
Nervous system disorders
cerebral hemorrhage
|
4.0%
2/50 • Number of events 2 • within 1 year after investigated device implanted
|
|
Nervous system disorders
subdural hematoma
|
4.0%
2/50 • Number of events 2 • within 1 year after investigated device implanted
|
|
Nervous system disorders
intracranial infection
|
2.0%
1/50 • Number of events 1 • within 1 year after investigated device implanted
|
|
Investigations
shunt device disorder
|
2.0%
1/50 • Number of events 1 • within 1 year after investigated device implanted
|
|
Investigations
shunt device occlusion
|
2.0%
1/50 • Number of events 1 • within 1 year after investigated device implanted
|
|
Investigations
shunt blockage
|
2.0%
1/50 • Number of events 1 • within 1 year after investigated device implanted
|
|
Metabolism and nutrition disorders
Electrolyte disorders
|
2.0%
1/50 • Number of events 1 • within 1 year after investigated device implanted
|
|
Infections and infestations
Infectious pneumonia
|
2.0%
1/50 • Number of events 1 • within 1 year after investigated device implanted
|
|
Infections and infestations
Urinary tract infection
|
2.0%
1/50 • Number of events 1 • within 1 year after investigated device implanted
|
|
Infections and infestations
Gastroenteritis
|
2.0%
1/50 • Number of events 1 • within 1 year after investigated device implanted
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
2.0%
1/50 • Number of events 1 • within 1 year after investigated device implanted
|
|
Nervous system disorders
Demyelination
|
2.0%
1/50 • Number of events 1 • within 1 year after investigated device implanted
|
|
Nervous system disorders
Infantile spasms
|
2.0%
1/50 • Number of events 1 • within 1 year after investigated device implanted
|
|
Nervous system disorders
Epilepsia
|
2.0%
1/50 • Number of events 1 • within 1 year after investigated device implanted
|
Other adverse events
| Measure |
Bactiseal Catheter Arm
n=50 participants at risk
Hydrocephalus subjects implanted with a Bactiseal catheter for one year.
|
|---|---|
|
Gastrointestinal disorders
diarrhea
|
16.0%
8/50 • Number of events 8 • within 1 year after investigated device implanted
|
|
Respiratory, thoracic and mediastinal disorders
respiratory infection
|
12.0%
6/50 • Number of events 6 • within 1 year after investigated device implanted
|
|
Infections and infestations
fever
|
10.0%
5/50 • Number of events 5 • within 1 year after investigated device implanted
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
8.0%
4/50 • Number of events 4 • within 1 year after investigated device implanted
|
|
Nervous system disorders
Cerebral hemorrhage
|
4.0%
2/50 • Number of events 2 • within 1 year after investigated device implanted
|
|
Nervous system disorders
Subdural hematoma
|
4.0%
2/50 • Number of events 2 • within 1 year after investigated device implanted
|
|
Nervous system disorders
Epilepsia
|
4.0%
2/50 • Number of events 2 • within 1 year after investigated device implanted
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
4.0%
2/50 • Number of events 2 • within 1 year after investigated device implanted
|
Additional Information
Dr. Hua Tang
Integra LifeSciences (Shanghai) Co., Ltd.
Phone: 0086 21 63179772
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60