Recruiting

PuraStat

Sponsor:

Endeavor Health

Code:

NCT07789041

Conditions

BPH (Benign Prostatic Hyperplasia)

BPH With Symptomatic Lower Urinary Tract Symptoms

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PuraStat hydrogel and the syringe

Study Details

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

Study ID

NCT07789041

Start date

Aug 12, 2025

Status verified date

Feb, 2026

Completion date

Dec 12, 2026

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Pooja Research Manager, MS MHA

847-503-34280PTalaty@northshore.org

Locations

Glenbrook Hospital- Endeavor Health

Recruiting

Glenview, Illinois, United States, 60026

Contacts

Pooja Talaty, MS MHA

847-503-4280PTalaty@northshore.org

Principal Investigator:

Brian T Helfand, MD PhD

More Information

Sponsor

Endeavor Health

Last update posted

Aug 27, 2026

Last verified

Feb, 2026

Keywords

  • PuraStat,Aquablation
  • BPH
  • Lower urinary tract symptoms

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Endeavor Health on 2026-08-27.