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The Zenflow Spring System Feasibility and Safety Study

NCT02786290 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-02-06

No results posted yet for this study

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).

Conditions

  • Benign Prostatic Hyperplasia

Interventions

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.

Sponsors & Collaborators

  • Zenflow, Inc.

    lead INDUSTRY

Principal Investigators

  • Peter Gilling, MD · Tauranga Urology Research Ltd.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2019-12-31
Completion
2020-01-31

Countries

  • Bulgaria
  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02786290 on ClinicalTrials.gov