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NCT05400980 · ClinicalTrials.gov registry record · NA
Expander-2 Trial: Randomized Study to Evaluate Safety & Efficacy of the Urocross® Expander System & Retrieval Sheath
A NA study of Benign Prostatic Hyperplasia, sponsored by Prodeon Medical.
- Active
- Registry status
- NA
- Development phase
- 240
- Enrollment target
- 2
- Study locations
NCT05400980: Active NA study of Benign Prostatic Hyperplasia, sponsored by Prodeon Medical.
NCT05400980 is a NA study of Benign Prostatic Hyperplasia that is active but no longer recruiting, run by Prodeon Medical. The registered enrollment target is 240 participants, below the 544-participant average among 29 other Benign Prostatic Hyperplasia trials with a reported enrollment target (56% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05400980, a NA study of Benign Prostatic Hyperplasia, is active but no longer recruiting, sponsored by Prodeon Medical.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 240 participants
- Enrollment target
- 2
- Study locations
Study Summary
To demonstrate the safety and efficacy of the Urocross Expander System/Retrieval Sheath and the procedure to treat patients with symptomatic Benign Prostatic Hyperplasia (BPH).
Primary Outcome
The rate of extended post-operative urinary catheterization (more than 7 days) from treatment for inability to void.
Conditions Studied
Interventions
- DEVICE Urocross implant
- DIAGNOSTIC_TEST Sham-control
Study Locations (2)
Illinois
- Loyola University Medical Center - Maywood
Virginia
- Virginia Tech-Carilion School of Medicine - Roanoke
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2022-07-05 |
| Est. Completion | 2028-12 |
| Phase | NA |
What the registry record for NCT05400980 still lists
NCT05400980 is an interventional study that assigns participants to a tested intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap, below the 544-participant average among 29 other Benign Prostatic Hyperplasia trials with a reported enrollment target (56% lower).
The record links to 1 condition, with Benign Prostatic Hyperplasia appearing as the primary indexed condition, and to 2 interventions - of which Urocross implant is the first listed.
NCT05400980 reports a single indexed study location in Illinois, Virginia.
Frequently Asked Questions
What is clinical trial NCT05400980 about?
NCT05400980 is a clinical study titled "Expander-2 Trial: Randomized Study to Evaluate Safety & Efficacy of the Urocross® Expander System & Retrieval Sheath". To demonstrate the safety and efficacy of the Urocross Expander System/Retrieval Sheath and the procedure to treat patients with symptomatic Benign Prostatic Hyperplasia (BPH).
What is the current status of trial NCT05400980?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 240 participants. The study started on 2022-07-05. Estimated completion is 2028-12.
What conditions does trial NCT05400980 study?
This clinical trial studies the following conditions: Benign Prostatic Hyperplasia.
What interventions are being tested in trial NCT05400980?
The interventions under investigation include: Urocross implant (DEVICE), Sham-control (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT05400980?
This trial is sponsored by Prodeon Medical, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05400980 being conducted?
This trial has 2 study locations across Illinois, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05400980's enrollment target sits among peer trials
240 9th of 29 higher than 21 of 29 other Benign Prostatic Hyperplasia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Benign Prostatic Hyperplasia 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.
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