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

NCT07789041 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-08-27

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • PROCEPT BioRobotics

    collaborator INDUSTRY

  • Endeavor Health

    lead OTHER

Principal Investigators

  • Alexander P Glaser, MD · Endeavor Health

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-12
Primary Completion
2026-09-01
Completion
2026-12-12
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07789041 on ClinicalTrials.gov