CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 130 enrolled
Drug / intervention
Hakim Shunt Programmable Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04285489
NCT04285489N/ACompleted

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

Integra LifeSciences Corporation·observational·Posted Feb 26, 2020·Updated Nov 5, 2021

In Brief

An observational study evaluating Hakim Shunt Programmable System for Hydrocephalus. Completed, enrolled 130 participants across 5 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsHydrocephalus
CountriesChina
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedFeb 26, 2020
Enrollment StartMay 2, 2020
Primary CompletionJul 28, 2020
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 6.4 years ago

Interventions

Hakim Shunt Programmable Systemdevice

patient accept Hakim Shunt Programmable System due to HCP