RADA16 for Aquablation Day Case

NCT ID: NCT06948331

Last Updated: 2025-04-29

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-01

Study Completion Date

2025-09-01

Brief Summary

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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).

Detailed Description

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Conditions

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Hematuria Benign Prostatic Hyperplasia Lower Urinary Tract Symptoms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

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.

Group Type EXPERIMENTAL

PuraStat

Intervention Type 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.

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

• Any man undergoing Aquablation for LUTS due to BPH

Exclusion Criteria

• Unwilling to sign consent
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

Central Contacts

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Majlinda Tafa, MD

Role: CONTACT

(646) 825-6338

Christopher Kelly, MD

Role: CONTACT

(646) 754-2462

Other Identifiers

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25-00109

Identifier Type: -

Identifier Source: org_study_id

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