A Phase 2 interventional study of PuraStat in Hematuria, Benign Prostatic Hyperplasia and Lower Urinary Tract Symptoms, sponsored by NYU Langone Health. Not yet recruiting at 1 site in United States. Open to male participants. Per ClinicalTrials.gov, last updated 2026-02-27.
Sponsored by NYU Langone Health · Phase 2, Interventional, and Supportive care
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).
Exclusion Criteria:
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.
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.
Percentage of Patients Discharged the Same Day as Aquablation
Time frame: Day 1 (Operative Visit)
Mean Post-Operation Hematuria Grade
The mean hematuria grade noticed 1-3 hours post procedure.
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
Plan to share: Yes — 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.
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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