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Procedure

Aquablation Therapy for Enlarged Prostate (AQUA Trial)

N/A

Recruiting

Led By Naeem Bhojani, MD

Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient is mentally capable and willing to sign a study-specific informed consent form

Patient has diagnosis of LUTS due to BPH

Must not have

Contraindications for general and spinal anesthesia

Patient is unwilling to accept a blood transfusion if required

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will assess the use of the Aquablation therapy, a robotic system that combines cystoscopic visualization, ultrasound imaging and advanced planning software to treat LUTS due to BPH and compare the percentage of patients discharged the same day of surgery.

Who is the study for?

This trial is for men with moderate to severe lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH), who can consent, follow instructions, and complete study visits. It's not for those who can't have general/spinal anesthesia, refuse blood transfusions, or stop certain medications like anticoagulants before treatment.

What is being tested?

The trial tests the AQUABEAM Robotic System and Apogee 2300 Ultrasound System on BPH patients. It aims to assess efficacy and safety of these technologies in prostate tissue removal via water jet ablation and compare same-day discharge rates among participants.

What are the potential side effects?

While specific side effects are not listed here, similar procedures may include risks such as bleeding, infection risk from surgery, possible discomfort from the procedure itself or anesthesia-related complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am mentally capable and willing to sign the consent form.

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I have been diagnosed with urinary symptoms due to an enlarged prostate.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot have general or spinal anesthesia due to health risks.

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I am not willing to receive a blood transfusion.

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I cannot stop taking my blood thinners or anti-inflammatory medications for treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rate of Unanticipated Serious Adverse Effect (USADE)

The change of the International Prostate Symptom Score (IPSS) from baseline to 3 months

Secondary study objectives

Identification of the anatomical landmarks

Other study objectives

Change in uroflow measurements from baseline to 3 month follow up visit

Operation time

Percentage of study subjects who were discharged on the day of surgery

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: AquablationExperimental Treatment2 Interventions

The participant will undergo aquablation procedure for Benign Prostate Hypeplasia (BPH) treatment using the AQUABEAM Robotic System and Ultrasound Accessories

0 / 5Eligibility criteria met