NCT03395522

Study to Assess the Efficacy of the iTind in Subjects With Symptomatic BPH

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)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 149 (actual)
• Sponsor: Medi-Tate Ltd. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• BPH

Interventions

Type	Name	Description
DEVICE	iTind	device implanted for 5-7 days

Timeline

• Start date: 2018-02-18
• Primary completion: 2023-06-18
• Completion: 2025-04-25
• First posted: 2018-01-10
• Last updated: 2023-10-23

Locations

12 sites across 6 countries: Australia, France, Germany, Italy, Spain, Switzerland