Use of PuraStat Following Aquablation to Determine if There is Change in Hematuria & Probability of Same Day Discharge (PuraStat)

August 24, 2026 updated by: Alexander Glaser, Endeavor Health

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Illinois
      • Glenview, Illinois, United States, 60026
        • Recruiting
        • Glenbrook Hospital- Endeavor Health
        • Sub-Investigator:
          • Andrew Higgins, MD
        • Contact:
        • Principal Investigator:
          • Brian T Helfand, MD PhD
        • Sub-Investigator:
          • Alexander P Glaser, MD
        • Sub-Investigator:
          • James T Kearns, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No PuraStat after the Aquablation procedure
Patient will not receive PuraStat after the Aquablation procedure
Experimental: PuraStat after the Aquablation procedure
Receive PuraStat after the Aquablation procedure
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 to 3 hours post procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients discharged on the same day
Time Frame: Postoperative Week 1
Examine whether the device helps recover more quickly and be discharged the same day, which currently happens in only 1% of cases.
Postoperative Week 1
Patient Reported Outcome Measure IPSS questionnaire
Time Frame: From Enrollment to 30 days post procedure
International Prostate Symptom Score (IPSS), Min 0 Max 35 (Worst symptoms)
From Enrollment to 30 days post procedure
Patient Reported Outcome Measures LURN SI-29 questionnaire
Time Frame: From Enrollment to 30 days post procedure
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
From Enrollment to 30 days post procedure
Patient Reported Outcome Measures SHIM questionnaire
Time Frame: From Enrollment to 30 days post procedure
Sexual health inventory for men, Min 1 (Worst Sexual health) Max 25 ( Best Sexual Health)
From Enrollment to 30 days post procedure
Patient Reported Outcome Measures MSHQ-EjD questionnaire
Time Frame: From Enrollment to 30 days post procedure
Male Sexual Health Questionnaire - Ejaculatory Dysfunction, Min 1 ( Worst) Max 15 ( Best)
From Enrollment to 30 days post procedure
Patient Reported Outcome Measures Dysuria questionnaire
Time Frame: 30 days post procedure
Difficult urination, Min 0 Max 5 (Worst)
30 days post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Endeavor Health

Collaborators

PROCEPT BioRobotics

Investigators

  • Study Director: Alexander P Glaser, MD, Endeavor Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 12, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 12, 2026

Study Registration Dates

First Submitted

September 19, 2025

First Submitted That Met QC Criteria

August 24, 2026

First Posted (Actual)

August 27, 2026

Study Record Updates

Last Update Posted (Actual)

August 27, 2026

Last Update Submitted That Met QC Criteria

August 24, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P2025-0151

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data collected for the study will be published in peer reviewed Journals and in research presentations and abstracts.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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