RADA16 for Aquablation Day Case
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PuraStat.
- Who it may be relevant to
- Registry conditions: Hematuria, Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms. Basic parameters: No limits · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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).
Interventions
- Device 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.
Primary outcome measures
- Percentage of Patients Discharged the Same Day as Aquablation [Time frame: Day 1 (Operative Visit)]
Secondary outcome measures (2)
- Mean Post-Operation Hematuria Grade [Time frame: Day 1 (Up to Hour 3 Post-Op)]
- Percentage of Patients who Experience Dysuria during Follow-Up [Time frame: Up to Week 4 Post-Operation]
Eligibility criteria
Inclusion criteria
- Any man undergoing Aquablation for LUTS due to BPH
Exclusion criteria
- Unwilling to sign consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- NYU Langone Health — New York
Identifiers
NCT: NCT06948331 · 25-00109