Benign Prostatic HyperplasiaAHANCT03125863
Acute Hemostasis Following the Use of the AQUABEAM® System 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
A single-arm prospective, interventional clinical trial to evaluate the safety and performance of obtaining hemostasis with commercially approved catheters following prostate resection using the AquaBeam for treatment of LUTS resulting from BPH. Read more about this study
- Who is it for?
- Ages 40 to 85 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
- 21 participants
- Where
- 1 siteIndia
- Study dates
- 26 Aug 2016to 31 Jul 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 40 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male age from 40 through 85 years with LUTS due to BPH
Who cannot join
- Any severe illness that would prevent complete study participation or confound study results
Trial locations and contacts
1 site in 1 country.
About this study
A single-arm prospective, interventional clinical trial to evaluate the safety and performance of obtaining hemostasis with commercially approved catheters following prostate resection using the AquaBeam for treatment of LUTS resulting from BPH.
Read the detailed description
PROCEPT BioRobotics has developed the AquaBeam, 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 BPH. The AquaBeam System is intended for the resection and removal of prostate tissue in patients experiencing LUTS. The primary objective of the study is to evaluate the safety and performance of obtaining hemostasis with commercially approved catheters following prostate resection using the AquaBeam. The time frame of the study is 7 days. Up to 30 participants will be included in this single-site clinical trial. The trial is a single-arm prospective, interventional clinical study. Results will be analyzed to determine the safety and efficacy of commercially approved catheters for the achievement of acute hemostasis without the need for cauterization.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- AquaBeam System
- Keywords
- Image-guided, BPH, Aquablation, AQUABEAM, LUTS, Tissue resection, Robotics
- 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
The AquaBeam system delivers a high-velocity saline stream under precise electromechanical control and live ultrasound guidance to ablate prostatic glandular tissue without the production of heat. The physician uses ultrasound imaging to plan the treatment contour and depth to define the treatment region. The AquaBeam ablates the target tissue, adhering to the pre-defined treatment zone.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Subjects will receive treatment with the AquaBeam System to remove enlarged prostatic tissue. Following the aquablation intervention, a urinary catheter will be inserted to apply pressure on treated tissue for hemostasis. Receives: Device: AquaBeam System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of the intended surgical procedure
Measured: 7 days post-op
Proportion of subjects that require electrocautery or any other intervention post catheter removal.
Measured: 7 days post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study start26 Aug 2016
- Primary completion3 Sep 2016
- Study completion31 Jul 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
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- PROCEPT BioRobotics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ravindra Sabnis, MD, Principal investigator, Muljibhai Patel Urological Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03125863
- Sponsor's protocol ID
- TP0113
- Acronym
- AHA
- Status last verified
- Nov 2017
- First submitted
- 9 Aug 2016
- Last updated
- 14 Nov 2017
- 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 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Hemostasis Following the Use of the AQUABEAM® System for the Treatment of Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT03125863
- Acronym / sponsor ID
- AHA / TP0113
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- Image-guided, BPH, Aquablation, AQUABEAM, LUTS, Tissue resection, Robotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- PROCEPT BioRoboticsIndustry (pharma, biotech, devices)
- Study start
- 26 Aug 2016 (actual)
- Primary completion
- 3 Sep 2016 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 24 Apr 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.
A single-arm prospective, interventional clinical trial to evaluate the safety and performance of obtaining hemostasis with commercially approved catheters following prostate resection using the AquaBeam for treatment of LUTS resulting from BPH.
Detailed description
PROCEPT BioRobotics has developed the AquaBeam, 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 BPH. The AquaBeam System is intended for the resection and removal of prostate tissue in patients experiencing LUTS. The primary objective of the study is to evaluate the safety and performance of obtaining hemostasis with commercially approved catheters following prostate resection using the AquaBeam. The time frame of the study is 7 days. Up to 30 participants will be included in this single-site clinical trial. The trial is a single-arm prospective, interventional clinical study. Results will be analyzed to determine the safety and efficacy of commercially approved catheters for the achievement of acute hemostasis without the need for cauterization.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Device: AquaBeam SystemSubjects will receive treatment with the AquaBeam System to remove enlarged prostatic tissue. Following the aquablation intervention, a urinary catheter will be inserted to apply pressure on treated tissue for hemostasis. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male age from 40 through 85 years with LUTS due to BPH
Key exclusion criteria (1 listed)
- Any severe illness that would prevent complete study participation or confound study results
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 SystemThe AquaBeam system delivers a high-velocity saline stream under precise electromechanical control and live ultrasound guidance to ablate prostatic glandular tissue without the production of heat. The physician uses ultrasound imaging to plan the treatment contour and depth to define the treatment region. The AquaBeam ablates the target tissue, adhering to the pre-defined treatment zone. | Device | Treatment Arm |
Primary outcome
Completion of the intended surgical procedure
Time frame: 7 days post-op
Proportion of subjects that require electrocautery or any other intervention post catheter removal.
Time frame: 7 days post-op
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 14 Nov 2017.
- 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.
Ravindra Sabnis, MD principal investigator
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 1 inclusion and 1 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 14 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?
Completion of the intended surgical procedure (time frame: 7 days post-op). 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 14 Nov 2017.