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NCT03605745 · ClinicalTrials.gov registry record · NA
Minimally Invasive Prostatic Vapor Ablation for the Treatment of BPH in Large Prostates (Rezūm XL)
A NA study, sponsored by Boston Scientific Corporation.
- Terminated
- Registry status
- NA
- Development phase
- 47
- Enrollment target
NCT03605745: Clinical Trial NA study, sponsored by Boston Scientific Corporation.
NCT03605745 is a NA study that was terminated before completion, run by Boston Scientific Corporation. The registered enrollment target is 47 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03605745, a NA study, was terminated before completion, sponsored by Boston Scientific Corporation.
- TERMINATED
- Registry status
- NA
- Development phase
- 47 participants
- Enrollment target
Study Summary
Prospective, multicenter, single arm clinical trial designed to evaluate the safety of the Rezūm System in treating subjects with symptomatic BPH for prostate sizes \>80cm3 and ≤150 cm3.
Primary Outcome
The proportion of the intent-to-treat (ITT) analysis population that responds to the Rezum therapy is reported. A responder is defined as a subject who has an improvement in International Prostate Symptom Score (IPSS) \> 30% from baseline to 6 months post-therapy. IPSS scores range from 0 (no symptoms) to 35 (severe symptoms). Improvement in symptoms is shown by a reduction in score.
Interventions
- DEVICE Prostatic Vapor Ablation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2018-06-19 |
| Est. Completion | 2020-08-11 |
| Phase | NA |
Why NCT03605745 stopped before completion
NCT03605745 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Prostatic Vapor Ablation is the first listed.
NCT03605745 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03605745 about?
NCT03605745 is a clinical study titled "Minimally Invasive Prostatic Vapor Ablation for the Treatment of BPH in Large Prostates (Rezūm XL)". Prospective, multicenter, single arm clinical trial designed to evaluate the safety of the Rezūm System in treating subjects with symptomatic BPH for prostate sizes \>80cm3 and ≤150 cm3.
What is the current status of trial NCT03605745?
This trial is currently terminated. It is a NA study. The enrollment target is 47 participants. The study started on 2018-06-19. Estimated completion is 2020-08-11.
What interventions are being tested in trial NCT03605745?
The interventions under investigation include: Prostatic Vapor Ablation (DEVICE).
Who is sponsoring clinical trial NCT03605745?
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 NCT03605745's enrollment target sits among peer trials
47 1400th of 2000 higher than 599 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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