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Study to Assess the Efficacy of the iTind in Subjects With Symptomatic BPH — MT-06  

BPH Clinical Trial

Official title:
One-arm, Multi-center, International Prospective Study to Assess the Efficacy of Medi-tate Temporary Implantable Nitinol Device (iTind) in Subjects With Symptomatic Benign Prostatic Hyperplasia (BPH)

Clinical Trial Summary

A total of up to 200 Symptomatic BPH subjects subjects will be enrolled into the study. Study duration will be 12 months post implantation with a follow-up visits at Year 2 and Year 3.

Clinical Trial Description

Primary Study Objective: The study's primary objective is to assess the efficacy of the Medi-Tate iTind in subjects with symptomatic BPH by reduction of IPSS) (International Prostate Symptoms Score) score. Secondary Study Objectives: - To further evaluate the efficacy of Medi-Tate iTind as determined by increase of maximal urinary peak flow, satisfaction from the device and procedures, sex performance capabilities and ejaculation. - Safety will be assessed by the rate of complications attributed to the Medi-Tate iTind and its implantation/retrieval procedures. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03395522
Study type Interventional
Source Medi-Tate Ltd.
Contact
Status Active, not recruiting
Phase N/A
Start date February 18, 2018
Completion date April 25, 2025
View Details
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