NCT01436877

Assessing Safety & Efficacy of MediTate Temporary Implant in Subjects With Benign Prostate Hyperplasia

One-arm Feasibility and Prospective Pivotal Study to Assess the Safety and Efficacy of MediTate Temporary Implantable Nitinol Device (TIND) in Subjects Presenting Bladder Outlet Obstruction Secondary to BPH

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Medi-Tate Ltd. · Industry
• Sex: Male
• Age: 50 Years – 95 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety and efficacy of MediTate Temporary Implantable Nitinol Device (TIND) used to alleviate symptoms of Bladder Outlet Obstruction (BOO) secondary to Benign Prostate Hyperplasia (BPH).The TIND is inserted in the bladder neck and prostatic urethra under local anesthesia for few days and taken out some 5 days later in the doctors office.

Conditions

• Bladder Neck Obstruction
• Benign Prostate Hyperplasia

Interventions

Type	Name	Description
DEVICE	Insertion of Temporary Implantable Nitinol Device (TIND)	Subjects will be inserted with the Temporary Implantable Nitinol Device (TIND) to the bladder neck and urethral prostate for 5 days and thereafter the TIND will be withdrawn in the doctor office.

Timeline

• Start date: 2011-09-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2011-09-20
• Last updated: 2018-12-21

Locations

1 site across 1 country: Israel