RADA16 for Aquablation Day Case
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
AgeNot listed
SponsorNYU Langone Health
About 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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
PuraStat
DeviceSterile 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.
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: Men Undergoing AquablationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of Patients Discharged the Same Day as Aquablation
Time frame
Day 1 (Operative Visit)Secondary outcomes
1
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)2
Percentage of Patients who Experience Dysuria during Follow-Up
Time frame
Up to Week 4 Post-OperationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: