Benign Prostatic HyperplasiaABSNCT03167294
AQUABEAM India Study for the Treatment of Benign Prostatic Hyperplasia
A study testing AquaBeam System in people with Benign Prostatic Hyperplasia, run by PROCEPT BioRobotics at 1 site in India.
Trial summary
Single-arm prospective, interventional clinical trial. Results will be compared to a historical control in the treatment of benign prostatic hyperplasia Read more about this study
- Who is it for?
- Ages 50 to 80 years, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- 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
- 47 participants
- Where
- 1 siteIndia
- Study dates
- 14 Dec 2014to 27 Apr 2017
- 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 50 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male
- 50 - 80 years
- Moderate to severe BPH
- Subjects who have failed standard medical therapy
Who cannot join
- Size and width of prostate
- Medical condition or co-morbidities where BPH intervention would be contraindicated
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PROCEPT AQUABEAM Study for the Treatment of Benign Prostatic Hyperplasia (ABS)
Single-arm prospective, interventional clinical trial. Results will be compared to a historical control in the treatment of benign prostatic hyperplasia
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- AquaBeam System
- Keywords
- Aquablation, AQUABEAM, BPH, LUTS
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AquaBeam SystemDevice
Aquablation
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Other | AquaBeam System for resection and removal of prostatic tissue in males suffering from BPH Receives: Device: AquaBeam System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Device Performance Endpoint
The primary device performance endpoint is completion of the intended surgical procedure.
Measured: 6 months
Primary Safety Endpoint of the study is the perioperative complication rate.
The primary safety endpoint of the study is the perioperative complication rate
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2017
- Study start14 Dec 2014
- Primary completion30 Jun 2016
- Study completion27 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies 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
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- PROCEPT BioRobotics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ravindra Sabnis, Principal investigator, Chairman, department of Urology Muljibhai Patel Urological Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03167294
- Sponsor's protocol ID
- TP0032
- Acronym
- ABS
- Status last verified
- Nov 2017
- First submitted
- 11 Dec 2014
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROCEPT AQUABEAM Study for the Treatment of Benign Prostatic Hyperplasia (ABS)
- ClinicalTrials.gov ID
- NCT03167294
- Acronym / sponsor ID
- ABS / TP0032
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- Aquablation, AQUABEAM, BPH, LUTS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- PROCEPT BioRoboticsIndustry (pharma, biotech, devices)
- Study start
- 14 Dec 2014 (actual)
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 27 Apr 2017 (actual)
- First posted
- 25 May 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 prospective, interventional clinical trial. Results will be compared to a historical control in the treatment of benign prostatic hyperplasia
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Other | Device: AquaBeam SystemAquaBeam System for resection and removal of prostatic tissue in males suffering from BPH |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male
- 50 - 80 years
- Moderate to severe BPH
- Subjects who have failed standard medical therapy
Key exclusion criteria (2 listed)
- Size and width of prostate
- Medical condition or co-morbidities where BPH intervention would be contraindicated
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 | Device | Single Arm |
Primary outcome
Primary Device Performance Endpoint
Time frame: 6 months
The primary device performance endpoint is completion of the intended surgical procedure.
Primary Safety Endpoint of the study is the perioperative complication rate.
Time frame: 6 months
The primary safety endpoint of the study is the perioperative complication rate
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 17 Nov 2017.
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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.
Ravindra Sabnis principal investigator
Chairman, department of Urology Muljibhai Patel Urological Hospital
1 site 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, run by PROCEPT BioRobotics at 1 site in India.
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 2 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 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. 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?
Primary Device Performance Endpoint (time frame: 6 months). The study lists 2 primary outcomes in all. 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 17 Nov 2017.