Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
25 participants
INTERVENTIONAL
2025-05-01
2025-09-01
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Men Undergoing Aquablation
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
MALE
No
Sponsors
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NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Christopher Kelly, MD
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Locations
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NYU Langone Health
New York, New York, United States
Countries
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Central Contacts
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Other Identifiers
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25-00109
Identifier Type: -
Identifier Source: org_study_id
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