Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2026-02-25 @ 2:41 AM
Study NCT ID:
NCT03123250
Status:
COMPLETED
Last Update Posted:
2023-06-28
First Post:
2017-04-11
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue II
Sponsor:
PROCEPT BioRobotics
Organization:
Study Overview
Official Title:
Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue II
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WATERII
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: