MedTrace Logo

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

NCT02506465 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 185

Last updated 2022-02-28

Study results available
· View outcomes & findings →

Summary

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

Conditions

  • Benign Prostate Hyperplasia

Interventions

DEVICE

iTIND

Temporary Implantable Nitinol Device (iTIND)

PROCEDURE

Sham Arm

Foley catheter will be placed and immediately removed.

Sponsors & Collaborators

  • Medi-Tate Ltd.

    lead INDUSTRY

Principal Investigators

  • Sheldon Pike, MD · St. John's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2018-10-31
Completion
2018-10-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02506465 on ClinicalTrials.gov