A Phase 2 interventional study of PuraStat in Hematuria, Benign Prostatic Hyperplasia and Lower Urinary Tract Symptoms, sponsored by NYU Langone Health. Completed at 1 site in United States. Open to male participants. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by NYU Langone Health · Phase 2, Interventional, and Supportive care
Among 20 studies in Hematuria with a site in United States — 5 open to participants now, 6 under way, 2 of them phase 3. Hematuria · United States.
Among the 20 studies in Hematuria with a site in United States, this one is the 12th largest by enrollment of the 13 interventional ones, is one of 3 that started in 2026, is the only one in phase 2, and was the 17th registered.
67 studies on the registry are indexed under Hematuria; 18 are open to participants now.
This study's enrollment of 24 is below the median of 100 across 35 interventional studies indexed under Hematuria.
Browse Hematuria studies →5 of the 20 studies in Hematuria with a site in United States are open now, in 2 countries. Each count lists the studies.
Of the 10 Hematuria studies recruiting now, 7 (70%) set no upper age limit and 1 (10%) stop at 75 or younger; 2 take children under 18; 2 take healthy volunteers.
This study: male · no healthy volunteers.
The full table on the hub →20 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 3 started in 2026.
Median enrollment 138 across the 13 interventional studies, 1,115 across the 7 observational. Of the 10 that completed or were terminated, 2 (20%) have results posted.
7 of 20 have an industry lead sponsor. The 10 most frequent:
NYU Langone Health is the lead sponsor of 1,430 studies on the registry; 258 are open to participants now.
Of its 235 completed or terminated interventional studies of FDA-regulated products, 197 (84%) have results posted.
NYU Langone Health has 2 studies filed under Hematuria — fewer than ten, so there is no comparison to draw.
2 of the studies in Hematuria with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06870253Pangea Laboratory LLCEvaluating Bladder CARE™, a New Non-Invasive Urine Test, for Bladder Cancer Detection in Inconclusive Cases | 2027-03 |
| NCT05646485University of Texas Southwestern Medical CenterBladder Cancer Screening Trial | 2027-04 |
Among the 20 studies in Hematuria with a site in United States, from their registry updates:
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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, Statistical analysis plan
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.
No publications or documents are linked to this record.
Ran from May 2026 to primary completion in Sep 2026, 4 months.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 9, 2026: start Apr 2026 → May 2026, primary completion Jul 2026 → Sep 2026 and completion Aug 2026 → Oct 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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