NCT02786290

The Zenflow Spring System Feasibility and Safety Study

The Zenflow Spring System Feasibility and Safety Study (ZEST)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Zenflow, Inc. · Industry
• Sex: Male
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a First in Human study to assess the feasibility, safety and effectiveness of the Zenflow Spring System in relieving the symptoms of obstructive Benign Prostatic Hyperplasia (BPH).

Detailed description

The purpose of the Zenflow Study is to evaluate the feasibility and safety of a novel prostatic urethral implant for the treatment of Lower Urinary Tract Symptoms (LUTS) that arise due to bladder outlet obstruction (BOO), secondary to the presence of Benign Prostatic Hypertrophy (BPH). Effectiveness will also be measured. It is intended that the features of the Zenflow Spring will provide an effective office-based treatment and management therapy for BPH with little or no side effects.

Conditions

• Benign Prostatic Hyperplasia

Interventions

Type	Name	Description
DEVICE	Zenflow Spring System	The Zenflow Spring is a nitinol urethral implant for the treatment of Lower Urinary Tract Symptoms (LUTS) that arise due to bladder outlet obstruction (BOO), secondary to the presence of Benign Prostatic Hypertrophy (BPH). The device is intended to be a permanent implant however it may be removed if necessary.

Timeline

• Start date: 2016-04-01
• Primary completion: 2019-12-01
• Completion: 2020-01-01
• First posted: 2016-05-30
• Last updated: 2019-02-06

Locations

3 sites across 2 countries: Bulgaria, New Zealand