Endeavor Health
Randomized, single-blinded investigational study to assess the safety of PuraStat following the Aquablation procedure
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.
Inclusion Criteria: 1. Subject must be undergoing Aquablation 2. Subject is willing to comply with protocol requirements Exclusion Criteria: 1. Any significant medical condition which, in the attending physician's opinion, may interfere with the patient's optimal procedure 2. Known or suspected systemic or severe infection 3. Patient unable to give consent
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.
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