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

Part of paid clinical trials in Glenview, Illinois.

Sponsor
Endeavor Health
Study ID
NCT07789041
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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

Key Dates

First listed
Aug 27, 2026
Start date
Aug 12, 2025
Status verified
Feb 2026
Primary completion
Sep 1, 2026
Completion
Dec 12, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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

Primary Outcome Measure

Hematuria grade at 1-3 hours postop in the PACU [ Time Frame: 1 to 3 hours post procedure ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Glenbrook Hospital- Endeavor HealthGlenviewIllinois60026
Pooja Talaty, MS MHA
[email protected]
847-503-4280
Brian T Helfand, MD PhD (PRINCIPAL_INVESTIGATOR)
Alexander P Glaser, MD (SUB_INVESTIGATOR)
James T Kearns, MD (SUB_INVESTIGATOR)
Andrew Higgins, MD (SUB_INVESTIGATOR)

Find similar trials in Glenview, IL

By research site
Glenbrook Hospital- Endeavor Health· Glenview, IL

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