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COMPLETED
NCT03395522
NA

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

Sponsor: Medi-Tate Ltd.

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

149

Start Date

2018-02-18

Completion Date

2025-04-25

Last Updated

2026-11-03

Healthy Volunteers

No

Conditions

Interventions

DEVICE

iTind

device implanted for 5-7 days

Locations (12)

Sydney Adventist Hospital Clinical School of the University of Sydney

Sydney, Australia

Hospital Center University De Bordeaux

Bordeaux, France

Hôpital Cochin

Paris, France

Hôpital Privé des Côtes d'Armor

Plérin, France

University Hospital Frankfurt

Frankfurt, Germany

Medical center - University of Freiburg

Freiburg im Breisgau, Germany

AOU di Catanzaro

Catanzaro, Italy

Azienda Ospedaliera Universitaria San Martino

Genova, Italy

Sant'Andrea Hospital

Rome, Italy

San Orbessano

Turin, Italy

Clínica CEMTRO Ventisquero la Condesa

Madrid, Spain

Cantonal Hospital St. Gallen

Sankt Gallen, Switzerland