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NCT03123250 · ClinicalTrials.gov registry record · NA
Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue II
A NA study, sponsored by PROCEPT BioRobotics.
- Completed
- Registry status
- NA
- Development phase
- 101
- Enrollment target
NCT03123250: Completed NA study, sponsored by PROCEPT BioRobotics.
NCT03123250 is a NA study that has completed, run by PROCEPT BioRobotics. The registered enrollment target is 101 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03123250, a NA study, has completed, sponsored by PROCEPT BioRobotics.
- COMPLETED
- Registry status
- NA
- Development phase
- 101 participants
- Enrollment target
Study Summary
Single-arm, interventional pivotal clinical trial collecting patient data from use of the AQUABEAM System, a personalized image-guided waterjet resection system that utilizes a high-velocity saline stream to resect and remove prostate tissue in males suffering from Lower Urinary Tract Symptoms (LUTS) due to Benign Prostatic Hyperplasia (BPH) with prostate volumes between 80 mL and 150 mL. The primary endpoints for safety and effectiveness will be measured at 3 months post-treatment. Treated subjects will be followed out to 60 months to collect long-term clinical data.
Primary Outcome
The percentage of subjects with adverse events rated as probably or definitely related to the study procedure classified as Clavien-Dindo Grade 2 or higher or any Grade 1 event resulting in persistent disability (e.g. ejaculatory disorder or erectile dysfunction) evidenced through 3 months post treatment.
Interventions
- DEVICE Aquablation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2017-08-14 |
| Est. Completion | 2022-12-20 |
| Phase | NA |
What the finished NCT03123250 record still lists
NCT03123250 is an interventional study that assigns participants to a tested intervention. The registered 101 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 (93% lower).
The record links to 0 conditions, and to 1 intervention - of which Aquablation is the first listed.
NCT03123250 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03123250 about?
NCT03123250 is a clinical study titled "Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue II". Single-arm, interventional pivotal clinical trial collecting patient data from use of the AQUABEAM System, a personalized image-guided waterjet resection system that utilizes a high-velocity saline stream to resect and remove prostate tissue in males suffering from Lower Urinary Tract Symptoms (LUTS...
What is the current status of trial NCT03123250?
This trial is currently completed. It is a NA study. The enrollment target is 101 participants. The study started on 2017-08-14. Estimated completion is 2022-12-20.
What interventions are being tested in trial NCT03123250?
The interventions under investigation include: Aquablation (DEVICE).
Who is sponsoring clinical trial NCT03123250?
This trial is sponsored by PROCEPT BioRobotics, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03123250's enrollment target sits among peer trials
101 840th of 2000 higher than 1,161 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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