Last updated on February 2018

Diversion-p64 Post Market Clinical Follow-Up Study to Assess Safety and Effectiveness of the p64 Flow Modulation Device


Brief description of study

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

Detailed Study 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.

Clinical Study Identifier: NCT02600364

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Christian Loehr, Dr.

Knappschaftskrankenhaus Recklinghausen
Recklinghausen, Germany
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