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Clinical Trial Summary

The purpose of this study is to assess safety and effectiveness of the p64 Flow Modulation Device.


Clinical Trial Description

Title: Diversion-p64. Device: p64 Flow Modulation Device. Study design: Prospective, multicenter, single arm Post Market Clinical Follow-Up Study. Purpose: To assess safety and effectiveness of p64. Study duration: 48 months. Sample Size: 400 patients. Number of sites: > 20. Follow-up intervals: Two independent follow-ups (after 3-6 and 7-12 months) according to site specific standard. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02600364
Study type Observational
Source Phenox GmbH
Contact
Status Completed
Phase
Start date December 2015
Completion date June 2020

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