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

NACompletedINTERVENTIONAL
Enrollment

185

Participants

Timeline

Start Date

July 31, 2015

Primary Completion Date

October 31, 2018

Study Completion Date

October 31, 2018

Conditions
Benign Prostate Hyperplasia
Interventions
DEVICE

iTIND

Temporary Implantable Nitinol Device (iTIND)

PROCEDURE

Sham Arm

Foley catheter will be placed and immediately removed.

Trial Locations (13)

10016

Manhattan Medical research, Manhattan

10065

Weill cornell, Manhattan

11215

Methodist Hospital, Brooklyn

11501

Winthrop University, Garden City

11691

St John's Episcopal, Lawrence

11735

Integrated Medical Professionals, Long Island City

12601

Primier Medical Center, Poughkeepsie

21209

Chesapeake Urology Research Associates, Baltimore

29572

Carolina Uro Research Center, Myrtle Beach

33060

Clinical Research Center of Florida, Pompano Beach

08857

Premier Urology Group, New York

Unknown

CIUSS de l'Estrie-CHUS, Sherbrooke

Toronto, Toronto

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Medi-Tate Ltd.

INDUSTRY

NCT02506465 - Pivotal Study to Assess the Safety and Effectiveness of the iTind Device | Biotech Hunter | Biotech Hunter