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NCT02506465 · ClinicalTrials.gov registry record · NA
Pivotal Study to Assess the Safety and Effectiveness of the iTind Device
A NA study of Benign Prostate Hyperplasia, sponsored by Medi-Tate.
- Completed
- Registry status
- NA
- Development phase
- 185
- Enrollment target
- 13
- Study locations
NCT02506465: Completed NA study of Benign Prostate Hyperplasia, sponsored by Medi-Tate.
NCT02506465 is a NA study of Benign Prostate Hyperplasia that has completed, run by Medi-Tate. The registered enrollment target is 185 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (87% lower). The trial reports 13 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02506465, a NA study of Benign Prostate Hyperplasia, has completed, sponsored by Medi-Tate.
- COMPLETED
- Registry status
- NA
- Development phase
- 185 participants
- Enrollment target
- 13
- Study locations
Study Summary
The study objectives are to demonstrate the efficacy and safety of the Medi-Tate iTIND as compared to control group (catheter only).
Primary Outcome
Month 3 results in the IPSS Score in both arms IPSS - The International Prostate Symptom Score. Scale: minimum 0 (zero), maximum 35. Lower values are better.
Conditions Studied
Interventions
- DEVICE iTIND
- PROCEDURE Sham Arm
Study Locations (13)
New York
- Methodist Hospital - Brooklyn
- Winthrop University - Garden City
- St John's Episcopal - Lawrence
- Integrated Medical Professionals - Long Island City
- Manhattan Medical research - Manhattan
- Weill cornell - Manhattan
- Premier Urology Group - New York
- Primier Medical Center - Poughkeepsie
Florida
- Clinical Research Center of Florida - Pompano Beach
Maryland
- Chesapeake Urology Research Associates - Baltimore
South Carolina
- Carolina Uro Research Center - Myrtle Beach
Quebec
- CIUSS de l'Estrie-CHUS - Sherbrooke
Other
- Toronto - Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 185 participants |
| Start Date | 2015-07 |
| Est. Completion | 2018-10 |
| Phase | NA |
What the finished NCT02506465 record still lists
NCT02506465 is an interventional study that assigns participants to a tested intervention. The registered 185 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (87% lower).
The record links to 1 condition, with Benign Prostate Hyperplasia appearing as the primary indexed condition, and to 2 interventions - of which iTIND is the first listed.
NCT02506465 lists 13 locations in 6 states (New York, Florida, Maryland).
Frequently Asked Questions
What is clinical trial NCT02506465 about?
NCT02506465 is a clinical study titled "Pivotal Study to Assess the Safety and Effectiveness of the iTind Device". The study objectives are to demonstrate the efficacy and safety of the Medi-Tate iTIND as compared to control group (catheter only).
What is the current status of trial NCT02506465?
This trial is currently completed. It is a NA study. The enrollment target is 185 participants. The study started on 2015-07. Estimated completion is 2018-10.
What conditions does trial NCT02506465 study?
This clinical trial studies the following conditions: Benign Prostate Hyperplasia.
What interventions are being tested in trial NCT02506465?
The interventions under investigation include: iTIND (DEVICE), Sham Arm (PROCEDURE).
Who is sponsoring clinical trial NCT02506465?
This trial is sponsored by Medi-Tate, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02506465 being conducted?
This trial has 13 study locations across Florida, Maryland, New York, South Carolina, Quebec. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Benign Prostate Hyperplasia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02506465's enrollment target sits among peer trials
185 580th of 2000 higher than 1,420 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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