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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Men Undergoing Aquablation | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PuraStat | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Discharged the Same Day as Aquablation | Day 1 (Operative Visit) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Post-Operation Hematuria Grade | The mean hematuria grade noticed 1-3 hours post procedure. | Day 1 (Up to Hour 3 Post-Op) |
| Percentage of Patients who Experience Dysuria during Follow-Up | Up to Week 4 Post-Operation |
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Inclusion Criteria:
• Any man undergoing Aquablation for LUTS due to BPH
Exclusion Criteria:
• Unwilling to sign consent
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Majlinda Tafa, MD | Contact | (646) 825-6338 | majlinda.tafa@nyulangone.org | |
| Christopher Kelly, MD | Contact | (646) 754-2462 | chris.kelly@nyulangone.org |
| Name | Affiliation | Role |
|---|---|---|
| Christopher Kelly, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
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.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
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.
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| ID | Term |
|---|---|
| D006417 | Hematuria |
| D011470 | Prostatic Hyperplasia |
| D059411 | Lower Urinary Tract Symptoms |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |