Trials / Completed
CompletedNCT02600364
Diversion-p64 Post Market Clinical Follow-Up Study to Assess Safety and Effectiveness of the p64 Flow Modulation Device
Prospective, Multicenter, Single Arm Post Market Clinical Follow-Up Study to Assess Safety and Effectiveness of the p64 Flow Modulation Device
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 450 (actual)
- Sponsor
- Phenox GmbH · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess safety and effectiveness of the p64 Flow Modulation Device.
Detailed 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.
Conditions
Timeline
- Start date
- 2015-12-01
- Primary completion
- 2020-06-01
- Completion
- 2020-06-01
- First posted
- 2015-11-09
- Last updated
- 2020-11-20
Locations
26 sites across 10 countries: Argentina, Belgium, Bulgaria, France, Germany, Italy, Poland, Romania, Russia, United Kingdom
Source: ClinicalTrials.gov record NCT02600364. Inclusion in this directory is not an endorsement.