Global Post-Market Registry Using Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue (OPEN WATER)
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Aquablation is a minimally invasive transurethral surgical procedure using the AQUABEAM system, a personalized image-guided waterject resection system that utilizes a high-velocity saline stream to resect and remove prostate tissue.
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Layout table for eligibility information
Ages Eligible for Study:
Child, Adult, Older Adult
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Participants with lower urinary tract symptoms, including those with urinary retention, who meet all other enrollment criteria.
Subject has diagnosis of lower urinary tract symptoms due to benign prostatic enlargement causing bladder outlet obstruction or in urinary retention.
Prostate size ≥ 20 mL and ≤ 150 mL as measure by TRUS.
Patient is mentally capable and willing to sign a study-specific informed consent form.
Patients unable to stop anticoagulants, antiplatelet agents, or non-steroidal anti-inflammatory agents (NSAIDs, including aspirin greater or equal to 100mg) prior to treatment per standard of care.
History of gross haematuria.
Participants using systemic immune-suppressants including corticosteroids (except inhalants), known coagulopathy, or platelet disorder (except aspirin below 100mg/d).
Contraindication to both general and spinal anesthesia.
Any severe illness that would prevent complete study participation or confound study results.
Subject is unwilling to accept a transfusion should one be required.