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A Study on the Safety of Hakim Programmable Shunt System

NCT04285489 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 130

Last updated 2021-11-05

Study results available
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Summary

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

Interventions

DEVICE

Hakim Shunt Programmable System

patient accept Hakim Shunt Programmable System due to HCP

Sponsors & Collaborators

  • Integra LifeSciences Corporation

    lead INDUSTRY

Principal Investigators

  • Hua Tang, MD · Integra LifeSciences Corporation

Eligibility

Min Age
2 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-02
Primary Completion
2020-07-28
Completion
2020-07-28

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04285489 on ClinicalTrials.gov