NCT03577236

The Zenflow Spring System EU Safety and Performance Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Zenflow, Inc. · Industry
• Sex: Male
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

The objectives of the trial are to demonstrate the safety and performance of the Zenflow Spring System in relieving the symptoms of obstructive Benign Prostatic Hyperplasia (BPH).

Detailed 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 60 month follow-up visit.

Conditions

• Benign Prostatic Hyperplasia

Interventions

Type	Name	Description
DEVICE	Zenflow Spring System	The Zenflow Spring System consists of the Spring Delivery System with Implant, Spring Scope, Camera Control Unit (CCU), Measurement Tool, and Spring Retrieval Tool.

Timeline

• Start date: 2019-01-16
• Primary completion: 2022-12-01
• Completion: 2024-05-30
• First posted: 2018-07-05
• Last updated: 2021-07-22

Locations

5 sites across 2 countries: Australia, New Zealand