The Zenflow Spring System EU Safety and Performance Study
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Benign Prostatic Hyperplasia
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Multi-center, prospective, single-arm.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 45 years and 125 years
- Gender
- Only males
Description
A multi-center, prospective, single arm safety and performance trial. Subjects will be treated either in the Investigator's out-patient treatment room or in the OR, with local anaesthesia only. All subjects will be followed for the entire duration of the study until exit after the 24 month follow-up...
A multi-center, prospective, single arm safety and performance trial. Subjects will be treated either in the Investigator's out-patient treatment room or in the OR, with local anaesthesia only. All subjects will be followed for the entire duration of the study until exit after the 24 month follow-up visit.
Tracking Information
- NCT #
- NCT03577236
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Peter Gilling, MD Tauranga Urology Research Ltd.
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