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NCT Number: NCT06948331

RADA16 for Aquablation Day Case

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).

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Key information

Conditions

Hematuria Benign Prostatic Hyperplasia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Hemorrhage Lower Urinary Tract Symptoms Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Hyperplasia Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Any man undergoing Aquablation for LUTS due to BPH

Exclusion criteria

  • Unwilling to sign consent

Treatment and study plan

PuraStat

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.

Primary outcomes

  1. Percentage of Patients Discharged the Same Day as Aquablation

    Time frame: Day 1 (Operative Visit)

Secondary outcomes

  1. Mean Post-Operation Hematuria Grade

    Time frame: Day 1 (Up to Hour 3 Post-Op)

    The mean hematuria grade noticed 1-3 hours post procedure.

  2. Percentage of Patients who Experience Dysuria during Follow-Up

    Time frame: Up to Week 4 Post-Operation

Study contacts

Contact information is provided by the study sponsor or research team.

Christopher Kelly, MD

CONTACT

[email protected]

(646) 754-2462

Majlinda Tafa, MD

CONTACT

[email protected]

(646) 825-6338

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study 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

Acronym: RAD

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 29, 2025
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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