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The Zenflow Spring System Feasibility and Safety Study

2016-05-31 15:08:21 | BioPortfolio

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).

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Benign Prostatic Hyperplasia

Intervention

Zenflow Spring System

Location

MBAL "Tokuda Bolnitsa Sofia" AD
Sofia
Nelson
Bulgaria
1407

Status

Recruiting

Source

Zenflow, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-05-31T15:08:21-0400

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The Zenflow Spring System Safety, Performance and Effectiveness Study

This is a clinical evaluation to assess the safety and performance of the Zenflow Spring System when used as intended to relieve symptoms of obstructive Benign Prostatic Hyperplasia (BPH).

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This is a clinical evaluation to assess the safety and performance of the Zenflow Spring System when used as intended to relieve symptoms of obstructive Benign Prostatic Hyperplasia (BPH).

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PubMed Articles [9995 Associated PubMed Articles listed on BioPortfolio]

Benign prostatic hyperplasia.

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Medical and Biotech [MESH] Definitions

Tissue ablation of the PROSTATE performed by ultrasound from a transducer placed in the RECTUM. The procedure is used to treat prostate cancer (PROSTATIC NEOPLASMS) and benign prostatic hypertrophy (PROSTATIC HYPERPLASIA).

An orally active TESTOSTERONE 5-ALPHA-REDUCTASE inhibitor. It is used as a surgical alternative for treatment of benign prostatic hyperplasia.

A 5-ALPHA-REDUCTASE INHIBITOR that is reported to inhibit both type-1 and type2 isoforms of the enzyme and is used to treat BENIGN PROSTATIC HYPERPLASIA.

A carboline derivative and PHOSPHODIESTERASE 5 INHIBITOR that is used primarily to treat ERECTILE DYSFUNCTION; BENIGN PROSTATIC HYPERPLASIA and PRIMARY PULMONARY HYPERTENSION.

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