BPH (Benign Prostatic Hyperplasia)PuraStatNCT07789041
Use of PuraStat Following Aquablation to Determine if There is Change in Hematuria & Probability of Same Day Discharge
A study testing PuraStat hydrogel and the syringe in people with BPH (Benign Prostatic Hyperplasia) and BPH With Symptomatic Lower Urinary Tract Symptoms, run by Endeavor Health at 1 site in United States.
Trial summary
Randomized, single-blinded investigational study to assess the safety of PuraStat following the Aquablation procedure Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- BPH (Benign Prostatic Hyperplasia), BPH With Symptomatic Lower Urinary Tract Symptoms
- What is being tested?
- PuraStat hydrogel and the syringe
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2025to 12 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must be undergoing Aquablation
- Subject is willing to comply with protocol requirements
Who cannot join
- Any significant medical condition which, in the attending physician's opinion, may interfere with the patient's optimal procedure
- Known or suspected systemic or severe infection
- Patient unable to give consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Glenbrook Hospital- Endeavor Health
Glenview, Illinois, 60026
Pooja Talaty, MS MHA, 847-503-4280, PTalaty@northshore.org
Brian T Helfand, MD PhD
About this study
Official title: PuraStat for Aquablation Day Case (Use of PuraStat Following an Aquablation Procedure)
Randomized, single-blinded investigational study to assess the safety of PuraStat following the Aquablation procedure
Read the detailed description
This study will evaluate the safety and effectiveness of a device (PuraStat hydrogel and the syringe used to apply it - referred to as PuraStat, designed to help control bleeding after the subject's scheduled Aquablation procedure. To assess its effectiveness, investigators will take a picture of the color of your urethral Foley catheter and grade the amount of blood present 1-3 hours after surgery. Investigators will also examine whether the device helps subjects recover more quickly and be discharged the same day, which currently happens in only 1% of cases.
- Being tested
- PuraStat hydrogel and the syringe
- Keywords
- PuraStat,Aquablation, BPH, Lower urinary tract symptoms
- 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.
PuraStat hydrogel and the syringeDevice
PuraStat device is FDA-approved for other uses, such as gastrointestinal endoscopy and ENT (ear, nose, throat) procedures. Its use in this study for urology is investigational.
| Study group | Role | What they receive |
|---|---|---|
| No PuraStat after the Aquablation procedure | No intervention | Patient will not receive PuraStat after the Aquablation procedure |
| PuraStat after the Aquablation procedure | Experimental | Receive PuraStat after the Aquablation procedure Receives: Device: PuraStat hydrogel and the syringe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hematuria grade at 1-3 hours postop in the PACU
Grade the amount of blood present 1-3 hours after surgery Scale zero through Five
Measured: 1 to 3 hours post procedure
Secondary outcomes (6)
Percentage of patients discharged on the same day
Examine whether the device helps recover more quickly and be discharged the same day, which currently happens in only 1% of cases.
Measured: Postoperative Week 1
Patient Reported Outcome Measure IPSS questionnaire
International Prostate Symptom Score (IPSS), Min 0 Max 35 (Worst symptoms)
Measured: From Enrollment to 30 days post procedure
Patient Reported Outcome Measures LURN SI-29 questionnaire
Lower Urinary Research Network Symptom Index-29. Max 100 (Worst Symptoms), Min 0 (Best Symptoms). Multiple health domains are being evaluated such as incontinence, pain, voiding, urgency, nocturia, frequency
Measured: From Enrollment to 30 days post procedure
Patient Reported Outcome Measures SHIM questionnaire
Sexual health inventory for men, Min 1 (Worst Sexual health) Max 25 ( Best Sexual Health)
Measured: From Enrollment to 30 days post procedure
Patient Reported Outcome Measures MSHQ-EjD questionnaire
Male Sexual Health Questionnaire - Ejaculatory Dysfunction, Min 1 ( Worst) Max 15 ( Best)
Measured: From Enrollment to 30 days post procedure
Patient Reported Outcome Measures Dysuria questionnaire
Difficult urination, Min 0 Max 5 (Worst)
Measured: 30 days post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start12 Aug 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion12 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BPH (Benign Prostatic Hyperplasia)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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- PuraStat and non PuraStat
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Endeavor Health
- Sponsor type
- University, hospital or other
- Collaborators
- PROCEPT BioRobotics
- Responsible party
- Principal investigator, Alexander Glaser, Endeavor Health
- Investigators
- Alexander P Glaser, MD, Study director, Endeavor Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07789041
- Sponsor's protocol ID
- P2025-0151
- Acronym
- PuraStat
- Status last verified
- Feb 2026
- First submitted
- 19 Sep 2025
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Data collected for the study will be published in peer reviewed Journals and in research presentations and abstracts.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PuraStat for Aquablation Day Case (Use of PuraStat Following an Aquablation Procedure)
- ClinicalTrials.gov ID
- NCT07789041
- Acronym / sponsor ID
- PuraStat / P2025-0151
- Keywords
- PuraStat,Aquablation, BPH, Lower urinary tract symptoms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Endeavor HealthUniversity, hospital or other
- Collaborators
- PROCEPT BioRobotics
- Study start
- 12 Aug 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 12 Dec 2026 (estimated)
- First posted
- 27 Aug 2026 (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.
Randomized, single-blinded investigational study to assess the safety of PuraStat following the Aquablation procedure
Detailed description
This study will evaluate the safety and effectiveness of a device (PuraStat hydrogel and the syringe used to apply it - referred to as PuraStat, designed to help control bleeding after the subject's scheduled Aquablation procedure. To assess its effectiveness, investigators will take a picture of the color of your urethral Foley catheter and grade the amount of blood present 1-3 hours after surgery. Investigators will also examine whether the device helps subjects recover more quickly and be discharged the same day, which currently happens in only 1% of cases.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- PuraStat and non PuraStat
| Arm | Type | Receives |
|---|---|---|
| No PuraStat after the Aquablation procedure | No intervention | –Patient will not receive PuraStat after the Aquablation procedure |
| PuraStat after the Aquablation procedure | Experimental | Device: PuraStat hydrogel and the syringeReceive PuraStat after the Aquablation procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject must be undergoing Aquablation
- Subject is willing to comply with protocol requirements
Key exclusion criteria (3 listed)
- Any significant medical condition which, in the attending physician's opinion, may interfere with the patient's optimal procedure
- Known or suspected systemic or severe infection
- Patient unable to give consent
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 |
|---|---|---|
| PuraStat hydrogel and the syringePuraStat device is FDA-approved for other uses, such as gastrointestinal endoscopy and ENT (ear, nose, throat) procedures. Its use in this study for urology is investigational. | Device | PuraStat after the Aquablation procedure |
Primary outcome
Hematuria grade at 1-3 hours postop in the PACU
Time frame: 1 to 3 hours post procedure
Grade the amount of blood present 1-3 hours after surgery Scale zero through Five
6 secondary outcomes
Percentage of patients discharged on the same day
Time frame: Postoperative Week 1
Patient Reported Outcome Measure IPSS questionnaire
Time frame: From Enrollment to 30 days post procedure
Patient Reported Outcome Measures LURN SI-29 questionnaire
Time frame: From Enrollment to 30 days post procedure
Patient Reported Outcome Measures SHIM questionnaire
Time frame: From Enrollment to 30 days post procedure
Patient Reported Outcome Measures MSHQ-EjD questionnaire
Time frame: From Enrollment to 30 days post procedure
Patient Reported Outcome Measures Dysuria questionnaire
Time frame: 30 days post procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- PuraStat Technology, Product and mode of actionLink provided by the sponsor.
- Individual participant dataSharing planned: No. Data collected for the study will be published in peer reviewed Journals and in research presentations and abstracts.
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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.
Alexander P Glaser, MD study director
Endeavor Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PuraStat hydrogel and the syringe in people with BPH (Benign Prostatic Hyperplasia) and BPH With Symptomatic Lower Urinary Tract Symptoms, run by Endeavor Health at 1 site in United States.
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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 27 Aug 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pooja Research Manager, MS MHA (847-503-34280, PTalaty@northshore.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hematuria grade at 1-3 hours postop in the PACU (time frame: 1 to 3 hours post procedure). 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 27 Aug 2026.