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NCT Number: NCT07789041

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

Randomized, single-blinded investigational study to assess the safety of PuraStat following the Aquablation procedure

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Key information

Conditions

BPH (Benign Prostatic Hyperplasia) BPH With Symptomatic Lower Urinary Tract Symptoms Genital Diseases Genital Diseases, Male Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Hyperplasia Signs and Symptoms Urogenital Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Glenbrook Hospital- Endeavor Health

Glenview, Illinois, 60026, United States

Location status: Recruiting

Location contact

Alexander P Glaser, MD

SUB_INVESTIGATOR

Andrew Higgins, MD

SUB_INVESTIGATOR

Brian T Helfand, MD PhD

PRINCIPAL_INVESTIGATOR

James T Kearns, MD

SUB_INVESTIGATOR

Pooja Talaty, MS MHA

CONTACT

[email protected]

847-503-4280

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PuraStat hydrogel and the syringe

Device

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 outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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)

  3. 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

  4. 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)

  5. 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)

  6. Patient Reported Outcome Measures Dysuria questionnaire

    Time frame: 30 days post procedure

    Difficult urination, Min 0 Max 5 (Worst)

Study contacts

Contact information is provided by the study sponsor or research team.

Pooja Research Manager, MS MHA

CONTACT

[email protected]

847-503-34280

Sponsors and collaborators

Lead sponsor

Endeavor Health

Other

Collaborators

  • PROCEPT BioRobotics

Registry information

Official study title

PuraStat for Aquablation Day Case (Use of PuraStat Following an Aquablation Procedure)

Acronym: PuraStat

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 27, 2026
Registry last updated
Aug 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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