HydrocephalusNCT04285489

A Study on the Safety of Hakim Programmable Shunt System

An observational study of Hydrocephalus, run by Integra LifeSciences Corporation at 5 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 2 to 80 years
Conditions the study is for: Hydrocephalus
What is being tested?: Hakim Shunt Programmable System
Type of treatment: Medical device
How many people: 130 participants
Where: 5 sitesChina
Study dates: 2 May 2020to 28 Jul 2020
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 2 to 80 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Patients with an implanted Hakim catheter due to Hydrocephalus (HCP)

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.
Subject had an indication suitable to use Hakim Shunt Programmable System.
Subject received a Hakim Shunt Programmable System at least one year ago.

Who cannot join

Subject didn't have an indication suitable to use the product.
Subject was known to be allergic to a component or ingredient of the product to be implanted, including silicone tubing and other components.
According to the comprehensive judgment of an investigator, subject had an infection of the implant site when the shunt system was implanted, such as ventriculitis, meningitis, peritonitis, and local implant skin infection.
Subject was simultaneously implanted with another shunt system different from Hakim Shunt Programmable System.
Subject had a contraindication of the shunt operation.
Subject had uncorrected coagulopathy or any bleeding disorder.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

China5 sites

Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100053
West China Hospital of Sichuan University
Chengdu, Sichuan
Guangzhou Women and Children Medical Center
Guangzhou, Guangdong
Nanjing Brain Hospital Affiliated to Nanjing Medical University
Nanjing, Jiangsu
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei

Other trials in China

About this study

Official title: A Multi-center, Retrospective Registry Study on the Safety of Hakim Programmable Shunt System

This study aimed to collect safety information from subjects implanted with a shunt system (trade name: Hakim Shunt Programmable System) 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
Being tested: Hakim Shunt Programmable System
Medical subject headings: Hydrocephalus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Hakim Shunt Programmable SystemDevice
patient accept Hakim Shunt Programmable System due to HCP

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Non-infection Within One Year
Non-infection rate of a subject within one year
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 May 202028 Jul 2020

First posted26 Feb 2020
Study start2 May 2020
Primary completion28 Jul 2020
Study completion28 Jul 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: Retrospective
Enrolment: 130 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04285489
Sponsor's protocol ID: C-HAKIM-001
Status last verified: Nov 2021
First submitted: 24 Feb 2020
Last updated: 5 Nov 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Nov 2021. 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 Hakim Programmable Shunt System
ClinicalTrials.gov ID: NCT04285489
Acronym / sponsor ID: C-HAKIM-001
Conditions: Hydrocephalus
Study type: Observational
Recruitment status: Completed
Enrolment: 130 participants (actual)
Lead sponsor: Integra LifeSciences CorporationIndustry (pharma, biotech, devices)
Study start: 2 May 2020 (actual)
Primary completion: 28 Jul 2020 (actual)
Study completion: 28 Jul 2020 (actual)
First posted: 26 Feb 2020 (actual)
Results: Posted 21 Sep 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Retrospective

Who may qualify

Ages: 2 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Patients with an implanted Hakim catheter due to Hydrocephalus (HCP)

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.
Subject had an indication suitable to use Hakim Shunt Programmable System.
Subject received a Hakim Shunt Programmable System at least one year ago.

Key exclusion criteria (6 listed)

Subject didn't have an indication suitable to use the product.
Subject was known to be allergic to a component or ingredient of the product to be implanted, including silicone tubing and other components.
According to the comprehensive judgment of an investigator, subject had an infection of the implant site when the shunt system was implanted, such as ventriculitis, meningitis, peritonitis, and local implant skin infection.
Subject was simultaneously implanted with another shunt system different from Hakim Shunt Programmable System.
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
Hakim Shunt Programmable Systempatient accept Hakim Shunt Programmable System due to HCP	Device	–

Primary outcome

Number of Participants With Non-infection Within One Year
Time frame: 1 year
Non-infection rate of a subject within one year

Results and safety

Results posted to the registry on 21 Sep 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
HAKIM Programmable Shunt System Arm	130	130

Primary outcome: Number of Participants With Non-infection Within One Year

Time frame: 1 year. Count of participants. Unit: Participants

Measure	Treatment Arm, Single Arm Study n = 130
Value	5

Population analysed: 130 participants implanted Hakim shunting system for 1 year

Adverse events

Time frame: within 1 year after investigated device implanted. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
HAKIM Programmable Shunt System Arm	31 of 130 (23.8%)	9 of 130 (6.9%)	4 of 130

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Hydrocephalus

RecruitingPhase 2
CEUS Evaluation of Hydrocephalus in Neonates and Infants
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RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes
RecruitingObservational study
Natural History of Treated Neurocysticercosis and Long-Term Outcomes
Cysticercosis, Neurocysticercosis
RecruitingObservational study
Development of Non-Invasive Prenatal Diagnosis for Single Gene Disorders
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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 LifeSciences Corporation

5 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 5 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 5 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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 Sep 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?

Number of 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?

On the ClinicalTrials.gov record for NCT04285489.

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 5 Nov 2021.