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Post-Market Study to Assess iTind Safety in Comparison to UroLift
NCT04757116 · View on ClinicalTrials.gov ↗
Study Summary
The study objective is to evaluate the safety of the iTind device comparied to UroLift.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04757116
The ClinicalTrials.gov registry entry for NCT04757116 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 206 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Olympus Corporation of the Americas, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04757116 reports 18 study locations spanning 12 distinct geographic areas — top geographies include Texas, Other, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04757116?
The interventions under investigation include: iTind (DEVICE), UroLift (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04757116?
This trial is sponsored by Olympus Corporation of the Americas, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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