PuraStat for Enlarged Prostate

(RAD Trial)

Overseen By Christopher Kelly, MD

Age: Any Age

Sex: Male

Trial Phase: Phase 2

Sponsor: NYU Langone Health

Disqualifiers: Unwilling to sign consent

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 1 day

25 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

Research Team

Christopher Kelly, MD

Principal Investigator

NYU Langone Health

Eligibility Criteria

This trial is for men undergoing Aquablation therapy to treat lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH), commonly known as an enlarged prostate. Participants must be willing to sign consent.

Inclusion Criteria

I am a man getting Aquablation for urinary symptoms due to enlarged prostate.

Exclusion Criteria

Unwilling to sign consent

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo the Aquablation procedure followed by the application of PuraStat to assess reduction of hematuria

1 day

1 visit (in-person)

Follow-up

Participants are monitored for post-operative hematuria and discharge criteria

1 day

1 visit (in-person)

Treatment Details

Interventions

• PuraStat

Trial Overview The study is testing PuraStat, a product used after the Aquablation procedure, aiming to reduce blood in urine (hematuria) and potentially allow patients to go home the same day.

Participant Groups

Group I: Men Undergoing Aquablation Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+