At a glance
ClinicalIndex Comparison RecordN/ACompleted· 185 enrolled
Drug / intervention
iTIND +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Multi-center Prospective Study to Assess the Safety and Effectiveness of Medi-Tate i-Temporary Implantable Nitinol Device (iTind) in Subjects With Symptomatic Benign Prostatic Hyperplasia (BPH)
In Brief
A clinical study evaluating iTIND and Sham Arm for Benign Prostate Hyperplasia. Completed, enrolled 185 participants across 13 sites in 2 countries.
Detailed Summary
The study objectives are to demonstrate the efficacy and safety of the Medi-Tate iTIND as compared to control group (catheter only).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBenign Prostate Hyperplasia
CountriesCanada, United States
Collaborators--
Timeline
N/ACompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartJul 2015
First PostedJul 2015
Primary CompletionOct 2018
TodayJul 2026
First PostedJul 23, 2015
Enrollment StartJul 1, 2015
Primary CompletionOct 1, 2018
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 10.9 years ago
Interventions
iTINDdevice
Temporary Implantable Nitinol Device (iTIND)
Sham Armprocedure
Foley catheter will be placed and immediately removed.