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A Prospective Study to Observe the Mechanism of Action of the MediTate iTind in Subjects With Symptomatic BPH With MRI

BPH Clinical Trial

Official title:
A Pilot and Prospective Study to Observe the Mechanism of Action of Medi-Tate i-Temporary Implantable Nitinol Device (iTind) in Subjects With Symptomatic Benign Prostatic Hyperplasia (BPH) With Magnetic Resonance Imaging (MRI)

Clinical Trial Summary

A total of up to 15 eligible subjects will be enrolled into this open-labeled one-arm study designed to observe the mechanism of action of iTind when using MRI

Clinical Trial Description

Study Objective: To validate the iTind efficacy by using MRI in subjects with symptomatic BPH. Specifically the pressure points created by the iTind's struts and its implications on blood flow to the prostate will be assessed. Efficacy Endpoints: The endpoints of this study are: - Decrease in transition zone volume - Monitor size and location of ablative lesions - Monitor change in time of lesions - Monitor the correspondence change in prostate tissue All the above will be assessed by using MRI. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03994263
Study type Interventional
Source Medi-Tate Ltd.
Contact
Status Terminated
Phase N/A
Start date November 18, 2019
Completion date February 18, 2021
View Details
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