NCT07789041 · Endeavor Health
Use of PuraStat Following Aquablation to Determine if There is Change in Hematuria & Probability of Same Day Discharge
(PuraStat)
What this study is about
randomly assigned, single-blinded experimental study to assess the safety of PuraStat following the Aquablation procedure
View original scientific description
Randomized, single-blinded investigational study to assess the safety of PuraStat following the Aquablation procedure
Interventions
DEVICE
PuraStat hydrogel and the syringe
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.
Primary outcome measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Subject must be undergoing Aquablation
- Subject is willing to comply with protocol requirements
Exclusion criteria
- 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
Where
- Glenview, Illinois
Collaborators
PROCEPT BioRobotics
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 27, 2026 · Source of record for eligibility and locations