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

NCT07789041 | Recruiting FDA Device

• 1 other identifier: P2025-0151
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

BPH (Benign Prostatic Hyperplasia); BPH With Symptomatic Lower Urinary Tract Symptoms

Keywords

PuraStat,Aquablation; BPH; Lower urinary tract symptoms

Outcome Measures

Primary Outcomes (1)

• 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

  1 to 3 hours post procedure

Secondary Outcomes (6)

• Percentage of patients discharged on the same day

  Postoperative Week 1

• Patient Reported Outcome Measure IPSS questionnaire

  From Enrollment to 30 days post procedure

• Patient Reported Outcome Measures LURN SI-29 questionnaire

  From Enrollment to 30 days post procedure

• Patient Reported Outcome Measures SHIM questionnaire

  From Enrollment to 30 days post procedure

• Patient Reported Outcome Measures MSHQ-EjD questionnaire

  From Enrollment to 30 days post procedure

Study Arms (2)

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

Device: PuraStat hydrogel and the syringe

Interventions

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.

PuraStat after the Aquablation procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must be undergoing Aquablation
• Subject is willing to comply with protocol requirements

You may not qualify if:

• 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

Sponsors & Collaborators

• Endeavor Health: lead
• PROCEPT BioRobotics: collaborator

Study Sites (1)

Glenbrook Hospital- Endeavor Health

Glenview, Illinois, 60026, United States

RECRUITING

Related Links

• PuraStat Technology, Product and mode of action

MeSH Terms

Conditions

Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alexander P Glaser, MD

  Endeavor Health

  STUDY DIRECTOR

Central Study Contacts

Pooja Research Manager, MS MHA

CONTACT

847-503-34280; PTalaty@northshore.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chief of Urology and Director of Urology Research, Endeavor Health

Model Details: PuraStat and non PuraStat

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: August 27, 2026
• Study Start: August 12, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 12, 2026
• Last Updated: August 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)