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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
AQUA Trial 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.Check my eligibility
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.See study design
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.
AQUA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am mentally capable and willing to sign the consent form.
Select...
I have been diagnosed with urinary symptoms due to an enlarged prostate.
Select...
I am willing and able to follow the study's instructions and attend all visits.
AQUA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of Unanticipated Serious Adverse Effect (USADE)
The change of the International Prostate Symptom Score (IPSS) from baseline to 3 months
Secondary outcome measures
Identification of the anatomical landmarks
Other outcome measures
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 moreAQUA 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
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Who is running the clinical trial?
Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
366 Previous Clinical Trials
129,587 Total Patients Enrolled
PROCEPT BioRoboticsIndustry Sponsor
12 Previous Clinical Trials
989 Total Patients Enrolled
2 Trials studying Lower Urinary Tract Symptoms
246 Patients Enrolled for Lower Urinary Tract Symptoms
Naeem Bhojani, MDPrincipal InvestigatorCentre hospitalier de l'Université de Montréal (CHUM)
3 Previous Clinical Trials
373 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot have general or spinal anesthesia due to health risks.I am mentally capable and willing to sign the consent form.I have been diagnosed with urinary symptoms due to an enlarged prostate.I am willing and able to follow the study's instructions and attend all visits.I am not willing to receive a blood transfusion.I cannot stop taking my blood thinners or anti-inflammatory medications for treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Aquablation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are eligible to enroll in the research?
"Affirmative. Clinicaltrials.gov reveals that this clinical trial, first made public on February 16th 2023, is presently recruiting participants. The investigation needs to recruit 50 volunteers from a single medical centre."
Answered by AI
Does this study have any openings for new enrollees?
"Indeed, the clinicaltrials.gov database states that this medical trial is in its active recruitment phase. It was posted on February 16th 2023 and subsequently updated on the 24th of that month. The study aims to enroll 50 patients from 1 site."
Answered by AI
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