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RADA16 for Aquablation Day Case
Sponsor: NYU Langone Health
Summary
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).
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
Key Details
Gender
MALE
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
25
Start Date
2026-04-01
Completion Date
2026-08-01
Last Updated
2026-02-27
Healthy Volunteers
No
Interventions
PuraStat
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.
Locations (1)
NYU Langone Health
New York, New York, United States