Global Post-Market Registry Using Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

178 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-05

Study Completion Date

2020-02-29

Brief Summary

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The purpose of this study is to evaluate the efficacy of the AQUABEAM System for the treatment of Lower Urinary Tract Symptoms (LUTS) resulting from Benign Prostatic Hyperplasia (BPH).

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Detailed Description

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Conditions

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BPH

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Aquablation

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Male.
* 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.

Exclusion Criteria

* 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.

Eligible Sex

MALE

Accepts Healthy Volunteers

No