RADA16 for Aquablation Day Case

Phase 2

Not yet recruiting

• Conditions: Hematuria; Benign Prostatic Hyperplasia; Lower Urinary Tract Symptoms

• Registration Number: NCT06948331
• Lead Sponsor: NYU Langone Health

Brief 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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-21
• Study First Submitted QC: 2025-04-28
• Last Update Submitted: 2025-04-28
• Study First Posted: 2025-04-29
• Last Update Posted: 2025-04-29
• Study Start: 2025-05-01
• Primary Completion: 2025-08-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 25

Inclusion Criteria

• Any man undergoing Aquablation for LUTS due to BPH

Exclusion Criteria

• Unwilling to sign consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Percentage of Patients Discharged the Same Day as Aquablation	Day 1 (Operative Visit)

Secondary Outcome Measures

Name	Time	Method
Mean Post-Operation Hematuria Grade	Day 1 (Up to Hour 3 Post-Op)	The mean hematuria grade noticed 1-3 hours post procedure.
Percentage of Patients who Experience Dysuria during Follow-Up	Up to Week 4 Post-Operation

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States