What this study is
This is a pilot proof of concept single-arm study using PuraStat following Aquablation procedure to assess reduction of hematuria to allow for same day discharge.
The primary objective is to assess how PuraStat affects post-operative hematuria following Aquablation.
The secondary objective is to assess the number of patients discharged on the same day based on the hematuria criteria (Grade 0 and Grade I).
What's being tested
- PuraStat
Intervention · DEVICE
Sterile gel composed of synthetic peptide and sterile water; provided as a prefilled syringe. The will be applied to the inside of the prostate to help stop bleeding following Aquablation.
Study details
- Official title
- A Pilot Proof of Concept Single-arm Study Using PuraStat Following the Aquablation Procedure to Assess Reduction of Hematuria to Allow for Same Day Discharge
- Sponsor
- NYU Langone Health
- Conditions
- Hematuria · Benign Prostatic Hyperplasia · Lower Urinary Tract Symptoms
- Enrolling
- 25 people
- Starts
- 2025-05-01
- Est. completion
- 2025-09-01
- Design
- Open-label, single group, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Sex MALEHealthy volunteers Not acceptedYou may qualify if
- Any man undergoing Aquablation for LUTS due to BPH
You can't join if
- Unwilling to sign consent
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openNYU Langone Health
New York, New York, United States
Study team
Sponsor
NYU Langone Health
Study ID 25-00109
Principal investigator
Christopher Kelly, MD
NYU Langone Health
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.