RADA16 for Aquablation Day Case
RAD
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
1 other identifier
interventional
25
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Apr 2026
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 21, 2025
CompletedFirst Posted
Study publicly available on registry
April 29, 2025
CompletedStudy Start
First participant enrolled
April 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2026
February 27, 2026
February 1, 2026
3 months
April 21, 2025
February 25, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Patients Discharged the Same Day as Aquablation
Day 1 (Operative Visit)
Secondary Outcomes (2)
Mean Post-Operation Hematuria Grade
Day 1 (Up to Hour 3 Post-Op)
Percentage of Patients who Experience Dysuria during Follow-Up
Up to Week 4 Post-Operation
Study Arms (1)
Men Undergoing Aquablation
EXPERIMENTALFollowing 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Any man undergoing Aquablation for LUTS due to BPH
You may not qualify if:
- Unwilling to sign consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NYU Langone Health
New York, New York, 10016, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher Kelly, MD
NYU Langone Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 21, 2025
First Posted
April 29, 2025
Study Start
April 1, 2026
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
August 1, 2026
Last Updated
February 27, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
- Access Criteria
- The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to chris.kelly@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.
The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: chris.kelly@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.