RADA16 for Aquablation Day Case

NYU Langone Health

Status and phase: Not yet enrolling; Phase 2

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

Treatments: Device: PuraStat

Study type: Interventional

Funder types: Other

Identifiers

NCT06948331

25-00109

Details and patient eligibility

About

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).

Enrollment: 25 estimated patients

Sex: Male

Volunteers: No Healthy Volunteers

Inclusion criteria

• Any man undergoing Aquablation for LUTS due to BPH

Exclusion criteria

• Unwilling to sign consent

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Men Undergoing Aquablation

Experimental group

Description:

Following the Aquablation procedure for lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH), the surgeon will deliver the PuraStat to the prostatic fossa through the cystoscope sheath into the prostate urethra resection bed.

Treatment:

Device: PuraStat