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Pivotal Study to Assess the Safety and Effectiveness of the iTind Device

Benign Prostate Hyperplasia Clinical Trial

Official title:
Multi-center Prospective Study to Assess the Safety and Effectiveness of Medi-Tate i-Temporary Implantable Nitinol Device (iTind) in Subjects With Symptomatic Benign Prostatic Hyperplasia (BPH)

Clinical Trial Summary

The study objectives are to demonstrate the efficacy and safety of the Medi-Tate iTIND as compared to control group (catheter only).

Clinical Trial Description

Medi-Tate i-Temporary Implantable Nitinol Device (iTind) is intended to treat subjects with symptomatic BPH. A total of 150 subjects with symptomatic BPH will be enrolled into this study, according to eligibility criteria. Study duration is 12 months and includes 7 visits: screening, screening follow up, implantation, retrieval, 6 weeks follow up, 3 months follow up and 12 months follow up. iTind Device will be implanted for 5-7 days. Sham will be a routine Foley catheter procedure. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02506465
Study type Interventional
Source Medi-Tate Ltd.
Contact
Status Completed
Phase N/A
Start date July 2015
Completion date October 2018
View Details
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