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

NCT02974751 | Unknown

• 1 other identifier: TP0118
• Study Type: observational
• Target: 178
• Locations: 5 countries
• Sites: 5

Brief Summary

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).

Conditions

BPH

Keywords

Aquablation; AQUABEAM; BPH; LUTS

Outcome Measures

Primary Outcomes (1)

• IPSS score change

  3 months

Interventions

Aquablation PROCEDURE

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.

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants with lower urinary tract symptoms, including those with urinary retention, who meet all other enrollment criteria.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• PROCEPT BioRobotics: lead

Study Sites (5)

Royal Melbourne Hospital

Melbourne, Victoria, 3050, Australia

Location

Asklepios Klinikum Harburg

Hamburg, 21075, Germany

Location

American University of Beirut Medical Center

Beirut, Lebanon

Location

Tauranga Urology Research

Tauranga, 3112, New Zealand

Location

Frimley Park Hospital

Frimley, Surrey, GU16 7UJ, United Kingdom

Location

MeSH Terms

Interventions

Aquablation

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative; Prostatectomy; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2016
• First Posted: November 28, 2016
• Study Start: September 5, 2017
• Primary Completion: May 24, 2019
• Study Completion: February 29, 2020
• Last Updated: October 22, 2019

Record last verified: 2019-10

Locations

AU (1); GB (1); DE (1); LE (1); NZ (1)