Use of PuraStat Following Aquablation to Determine if There is Change in Hematuria & Probability of Same Day Discharge
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorEndeavor Health
About this trial
Randomized, single-blinded investigational study to assess the safety of PuraStat following the Aquablation procedure
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subject must be undergoing Aquablation
Subject is willing to comply with protocol requirements
Disqualifiers
Any significant medical condition which, in the attending physician's opinion, may interfere with the patient's optimal procedure
Known or suspected systemic or severe infection
Patient unable to give consent
Trial design
Design model
Parallel
Treatments tested in this trial
PuraStat hydrogel and the syringe
DevicePuraStat device is FDA-approved for other uses, such as gastrointestinal endoscopy and ENT (ear, nose, throat) procedures. Its use in this study for urology is investigational.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: No PuraStat after the Aquablation procedureNo intervention 0 interventions
Group B: PuraStat after the Aquablation procedureExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Hematuria grade at 1-3 hours postop in the PACU
Grade the amount of blood present 1-3 hours after surgery Scale zero through Five
Time frame
1 to 3 hours post procedureSecondary outcomes
1
Percentage of patients discharged on the same day
Examine whether the device helps recover more quickly and be discharged the same day, which currently happens in only 1% of cases.
Time frame
Postoperative Week 12
Patient Reported Outcome Measure IPSS questionnaire
International Prostate Symptom Score (IPSS), Min 0 Max 35 (Worst symptoms)
Time frame
From Enrollment to 30 days post procedure3
Patient Reported Outcome Measures LURN SI-29 questionnaire
Lower Urinary Research Network Symptom Index-29. Max 100 (Worst Symptoms), Min 0 (Best Symptoms). Multiple health domains are being evaluated such as incontinence, pain, voiding, urgency, nocturia, frequency
Time frame
From Enrollment to 30 days post procedure4
Patient Reported Outcome Measures SHIM questionnaire
Sexual health inventory for men, Min 1 (Worst Sexual health) Max 25 ( Best Sexual Health)
Time frame
From Enrollment to 30 days post procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Endeavor Health
Lead sponsor
PROCEPT BioRobotics
Collaborator
Source ClinicalTrials.gov