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NCT04757116 · ClinicalTrials.gov registry record · NA
Post-Market Study to Assess iTind Safety in Comparison to UroLift
A NA study of Benign Prostatic Hyperplasia (BPH), sponsored by Olympus Corporation of the Americas.
- Recruiting
- Registry status
- NA
- Development phase
- 206
- Enrollment target
- 18
- Study locations
NCT04757116: Recruiting NA study of Benign Prostatic Hyperplasia (BPH), sponsored by Olympus Corporation of the Americas.
NCT04757116 is a NA study of Benign Prostatic Hyperplasia (BPH) that is actively recruiting participants, run by Olympus Corporation of the Americas. The registered enrollment target is 206 participants, above the 45-participant average among 3 other Benign Prostatic Hyperplasia (BPH) trials with a reported enrollment target (358% higher). The trial reports 18 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04757116, a NA study of Benign Prostatic Hyperplasia (BPH), is actively recruiting participants, sponsored by Olympus Corporation of the Americas.
- RECRUITING
- Registry status
- NA
- Development phase
- 206 participants
- Enrollment target
- 18
- Study locations
Study Summary
The study objective is to evaluate the safety of the iTind device comparied to UroLift.
Primary Outcome
Difference in change of IPSS from baseline between iTind and UroLift groups at 3 months
Conditions Studied
Interventions
- DEVICE iTind
- PROCEDURE UroLift
Study Locations (18)
Texas
- Midtown Urology Associates - Austin
- Houston Metro Urology - Houston
- The Urology Place - San Antonio
Other
- Queen Margaret Hospital - Dunfermline
- Frimley Park Hospital - London
- Norfolk & Norwich University Hospital - Norwich
Arizona
- Mayo Clinic Arizona - Phoenix
- Arizona Urology Specialists - Tucson
California
- Urology Associates of Central California - Fresno
- Golden State Urology - Sacramento
Illinois
- NorthShore University Health System Research Institute - Evanston
Louisiana
- Southeast Louisiana Veterans Health Care System - New Orleans
Minnesota
- Minnesota Urology - Woodbury
Nebraska
- Adult & Pediatric Urology - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 206 participants |
| Start Date | 2022-09-26 |
| Est. Completion | 2031-12-31 |
| Phase | NA |
What NCT04757116 shows while recruiting
NCT04757116 is an interventional study that assigns participants to a tested intervention. The registered 206 participants enrollment target is mid-sized for trials with a published cap, above the 45-participant average among 3 other Benign Prostatic Hyperplasia (BPH) trials with a reported enrollment target (358% higher).
The record links to 1 condition, with Benign Prostatic Hyperplasia (BPH) appearing as the primary indexed condition, and to 2 interventions - of which iTind is the first listed.
NCT04757116 lists 18 locations in 12 states (Texas, Other, Arizona).
Frequently Asked Questions
What is clinical trial NCT04757116 about?
NCT04757116 is a clinical study titled "Post-Market Study to Assess iTind Safety in Comparison to UroLift". The study objective is to evaluate the safety of the iTind device comparied to UroLift.
What is the current status of trial NCT04757116?
This trial is currently recruiting. It is a NA study. The enrollment target is 206 participants. The study started on 2022-09-26. Estimated completion is 2031-12-31.
What conditions does trial NCT04757116 study?
This clinical trial studies the following conditions: Benign Prostatic Hyperplasia (BPH).
What interventions are being tested in trial NCT04757116?
The interventions under investigation include: iTind (DEVICE), UroLift (PROCEDURE).
Who is sponsoring clinical trial NCT04757116?
This trial is sponsored by Olympus Corporation of the Americas, which has 14 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04757116 being conducted?
This trial has 18 study locations across Arizona, California, Illinois, Louisiana, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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