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NCT01912339 · ClinicalTrials.gov registry record · NA
Safety and Efficacy Study for the Treatment of BPH (Enlarged Prostate)
A NA study, sponsored by Boston Scientific Corporation.
- Completed
- Registry status
- NA
- Development phase
- 197
- Enrollment target
NCT01912339: Completed NA study, sponsored by Boston Scientific Corporation.
NCT01912339 is a NA study that has completed, run by Boston Scientific Corporation. The registered enrollment target is 197 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01912339, a NA study, has completed, sponsored by Boston Scientific Corporation.
- COMPLETED
- Registry status
- NA
- Development phase
- 197 participants
- Enrollment target
Study Summary
To evaluate the safety and efficacy of the Rezūm System and assess its effect on urinary symptoms secondary to benign prostatic hyperplasia (BPH).
Primary Outcome
Comparison of the change in BPH symptoms as measured by IPSS change between the Treatment and Control arm at 3 months post-treatment. The IPSS is a well-validated, highly reliable and responsive American Urological Association symptom score (AUASS) assessment to identify the severity of BPH Symptoms. The first seven questions of the IPSS Questionnaire address frequency, nocturia, weak urinary stream, hesitancy, intermittence, incomplete emptying and urgency each on a scale of 0 to 5. The total s
Interventions
- DEVICE Rezum System
- PROCEDURE Rigid Cystoscopy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 197 participants |
| Start Date | 2013-07 |
| Est. Completion | 2016-10-17 |
| Phase | NA |
What the finished NCT01912339 record still lists
NCT01912339 is an interventional study that assigns participants to a tested intervention. The registered 197 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 (86% lower).
The record links to 0 conditions, and to 2 interventions - of which Rezum System is the first listed.
NCT01912339 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01912339 about?
NCT01912339 is a clinical study titled "Safety and Efficacy Study for the Treatment of BPH (Enlarged Prostate)". To evaluate the safety and efficacy of the Rezūm System and assess its effect on urinary symptoms secondary to benign prostatic hyperplasia (BPH).
What is the current status of trial NCT01912339?
This trial is currently completed. It is a NA study. The enrollment target is 197 participants. The study started on 2013-07. Estimated completion is 2016-10-17.
What interventions are being tested in trial NCT01912339?
The interventions under investigation include: Rezum System (DEVICE), Rigid Cystoscopy (PROCEDURE).
Who is sponsoring clinical trial NCT01912339?
This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01912339's enrollment target sits among peer trials
197 567th of 2000 higher than 1,434 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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