NCT02506465

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

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 185 (actual)
• Sponsor: Medi-Tate Ltd. · Industry
• Sex: Male
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Benign Prostate Hyperplasia

Interventions

Type	Name	Description
DEVICE	iTIND	Temporary Implantable Nitinol Device (iTIND)
PROCEDURE	Sham Arm	Foley catheter will be placed and immediately removed.

Timeline

• Start date: 2015-07-01
• Primary completion: 2018-10-01
• Completion: 2018-10-01
• First posted: 2015-07-23
• Last updated: 2022-02-28
• Results posted: 2022-02-08

Locations

13 sites across 2 countries: United States, Canada