Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue II

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Scottsdale/Phoenix, Arizona: 17-003336
    NCT ID: NCT03123250
    Sponsor Protocol Number: TP0124

About this study

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).The primary endpoints for safety and effectiveness will be measured at 3 months post-treatment. All treated subjects will be followed out to 12 months to collect long-term clinical data.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:  

  • Subject has diagnosis of lower urinary tract symptoms due to benign prostatic enlargement causing bladder outlet obstruction.

Exclusion Criteria:  

  • Any severe illness that would prevent complete study participation or confound study results.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Mitchell Humphreys, M.D.

Contact us for the latest status

Contact information:

Jill Weidknecht MBA/HCM, R.N.

(480)342-3007

Weidknecht.Jill@mayo.edu