Benign Prostatic Hyperplasia (BPH)NCT03191734
French Aquablation Clinical Investigation Using Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue
A study testing AQUABEAM System in people with Benign Prostatic Hyperplasia (BPH), run by PROCEPT BioRobotics at 3 sites in France.
Trial summary
Single arm, multi-center prospective clinical trial to determine the safety and effectiveness of the AQUABEAM System in the treatment of benign prostatic hyperplasia (BPH) in men 45 to 80 years of age. Read more about this study
- Who is it for?
- Ages 45 to 80 years, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia (BPH)
- What is being tested?
- AQUABEAM System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesFrance
- Study dates
- 19 Sep 2017to 7 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has diagnosis of lower urinary tract symptoms due to benign prostatic enlargement causing bladder outlet obstruction.
- History of inadequate response, contraindication or refusal to medical therapy for BPH.
- Age from 45 through 80 years.
- Prostate volume between 30mL and 80mL by transrectal ultrasound (TRUS) measured at baseline.
Who cannot join
- BMI ≥ 42.
- IPSS total score <12.
- History of prostate cancer or clinically significant elevated PSA value.
- History of bladder cancer actively treated within 2 years prior to the surgical procedure.
- Bladder calculus or clinically significant bladder diverticulum (e.g., pouch size >20% of full bladder size).
- Active infection, including urinary tract infection within 72 hours of the treatment procedure.
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- Prostatitis treated with antibiotics within 1 year of the surgical procedure.
- Subject ever diagnosed with urethral stricture, meatal stenosis, or bladder neck contracture, or has history of damage to external urinary sphincter.
- Subject has current diagnosis of stress urinary incontinence that requires treatment or daily pad or device use.
- Clinically significant abnormal serum creatinine measured within 30 days of treatment.
- Maximum urinary flow rate (Qmax) >15 mL/s or PVR > 300 mL measured by uroflowmetry test at baseline.
- Subject has been catheterized due to retention within 14 days prior to the surgical procedure.
- Subject has a history of intermittent self-catheterization.
- Previous prostate surgery or history of other lower urinary tract surgery such as e.g. urinary diversion, artificial urinary sphincter or penile prosthesis
- Subjects on anticoagulants or antiplatelet (if medication cannot be stopped before and after procedure) or known coagulopathy (except aspirin below 100mg/d)
- Any severe illness or psychiatric condition that would prevent study completion or confound study results.
- Subject taking systemic immune-suppressants including corticosteroids; unable to withhold non- steroidal anti-inflammatory agents (NSAIDs, including aspirin) for 3-5 days prior to treatment except for low dose aspirin (e.g. less than 100mg).
- Participants using medications specifically for bladder muscle problems (e.g., irritability). Use of medications with anticholinergic or similar properties is allowable provided the patient does not have documented adverse urinary side effects from these medications.
- Participating in another investigational study that could affect responses to the study device.
- Subject is unwilling to accept a transfusion should one be required.
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHU de Limoges
Limoges, 87042
Hôpital Cochin
Paris, 75014
Clinique Pasteur
Toulouse, 31300
About this study
Single arm, multi-center prospective clinical trial to determine the safety and effectiveness of the AQUABEAM System in the treatment of benign prostatic hyperplasia (BPH) in men 45 to 80 years of age.
- Conditions
- Benign Prostatic Hyperplasia (BPH)
- Being tested
- AQUABEAM System
- Keywords
- Lower Urinary Tract Symptoms (LUTS), Benign Prostatic Hyperplasia (BPH), AQUABEAM, Aquablation
- Medical subject headings
- Prostatic Hyperplasia, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AQUABEAM SystemDevice
Aquablation is a minimally invasive transurethral surgical procedure using the AQUABEAM system, a personalized image-guided waterject resection system that utilizes a high-pressure saline stream to resect and remove prostate tissue.
| Study group | Role | What they receive |
|---|---|---|
| AQUABEAM System | Experimental | AQUABEAM System Receives: Device: AQUABEAM System |
What is being measured
The primary outcome is the main question the study is designed to answer.
AQUABEAM System Effectiveness: IPSS total score change
IPSS total score change from baseline to 6 Month
Measured: 6 Months Post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2017
- Study start19 Sep 2017
- Primary completion2 Jul 2018
- Study completion7 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic Hyperplasia (BPH)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- PROCEPT BioRobotics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aurelien Descazeaud, MD, Principal investigator, Centre Hospitalier Régional Universitaire de Limoges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03191734
- Sponsor's protocol ID
- TP0112
- Status last verified
- Feb 2019
- First submitted
- 13 Jun 2017
- Last updated
- 22 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- French Aquablation Clinical Investigation Using Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue
- ClinicalTrials.gov ID
- NCT03191734
- Acronym / sponsor ID
- TP0112
- Conditions
- Benign Prostatic Hyperplasia (BPH)
- Keywords
- Lower Urinary Tract Symptoms (LUTS), Benign Prostatic Hyperplasia (BPH), AQUABEAM, Aquablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- PROCEPT BioRoboticsIndustry (pharma, biotech, devices)
- Study start
- 19 Sep 2017 (actual)
- Primary completion
- 2 Jul 2018 (actual)
- Study completion
- 7 Jan 2019 (actual)
- First posted
- 19 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Single arm, multi-center prospective clinical trial to determine the safety and effectiveness of the AQUABEAM System in the treatment of benign prostatic hyperplasia (BPH) in men 45 to 80 years of age.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AQUABEAM System | Experimental | Device: AQUABEAM SystemAQUABEAM System |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject has diagnosis of lower urinary tract symptoms due to benign prostatic enlargement causing bladder outlet obstruction.
- History of inadequate response, contraindication or refusal to medical therapy for BPH.
- Age from 45 through 80 years.
- Prostate volume between 30mL and 80mL by transrectal ultrasound (TRUS) measured at baseline.
Key exclusion criteria (20 listed)
- BMI ≥ 42.
- IPSS total score <12.
- History of prostate cancer or clinically significant elevated PSA value.
- History of bladder cancer actively treated within 2 years prior to the surgical procedure.
- Bladder calculus or clinically significant bladder diverticulum (e.g., pouch size >20% of full bladder size).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AQUABEAM SystemAquablation is a minimally invasive transurethral surgical procedure using the AQUABEAM system, a personalized image-guided waterject resection system that utilizes a high-pressure saline stream to resect and remove prostate tissue. | Device | AQUABEAM System |
Primary outcome
AQUABEAM System Effectiveness: IPSS total score change
Time frame: 6 Months Post-op
IPSS total score change from baseline to 6 Month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aurelien Descazeaud, MD principal investigator
Centre Hospitalier Régional Universitaire de Limoges
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AQUABEAM System in people with Benign Prostatic Hyperplasia (BPH), run by PROCEPT BioRobotics at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AQUABEAM System Effectiveness: IPSS total score change (time frame: 6 Months Post-op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2019.