Pivotal Study of Voro Urologic Scaffold
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age45+
SponsorLevee Medical, Inc.
About this trial
The objective of this study is to compare safety and effectiveness of the Voro Urologic Scaffold in adult men undergoing robotic assisted radical prostatectomy as compared to control arm.
The study is a multi-center, single blind, randomized, controlled trial. Up to 266 participants will be treated at up to 30 centers in the United States. The study will consist of a Baseline visit, implantation during robotic assisted radical prostatectomy (RARP), catheter removal, 6 weeks, 6 months, 12 months, 18 months, and 24 months.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male >= 45 years of age of any race and ethnic group
Diagnosed with prostate cancer and scheduled for radical prostatectomy
Gleason Grade Group 4 or lower
Prostate size less than 80 grams, as measured by Magnetic Resonance Imaging (MRI)
Disqualifiers
Malignant tumors with known bladder neck or urethral sphincter invasion or metastatic disease confirmed via baseline assessments (example [e.g.,] Multiparametric magnetic resonance imaging [mpMRI], bone scan)
History of urinary incontinence, including stress or urge urinary incontinence
Demonstration of SUI, such as positive 1 hour pad weight test or participant reported incontinence episodes
Currently treated with medications to treat overactive bladder (OAB)
Trial design
Design model
Parallel
Treatments tested in this trial
Voro Urologic Scaffold
DeviceThe Voro Urologic Scaffold is placed during the prostatectomy procedure after prostate removal.
Treatment groups
266 Participants
are divided into 2 treatment groupsGroup A: Voro Urologic Scaffold GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Number of participants with adverse events (AEs)
AE is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in participants during the course of the study, whether or not related to the investigational device.
Time frame
Upto 24 months2
Number of Participants With Adverse Events Categorized by Severity
The severity of adverse events as assessed by the investigator; events will be based on the definitions outlined in the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Time frame
Upto 24 months3
Number of participants achieving continence as measured by 1 hour provocative pad weight test at 6 weeks post-prostatectomy
Time frame
At 6 weeks post-prostatectomySecondary outcomes
1
Severity of incontinence as measured by 1 hour provocative pad weight test at 6 weeks
Time frame
At 6 weeks2
Severity of incontinence as measured by 1 hour provocative pad weight test at 6 months
Time frame
At 6 months3
Quality of Life (QoL) performance as assessed by the urinary domain of Expanded Prostate Cancer Index Composite (EPIC) Questionnaire
The Expanded Prostate Cancer Index Composite is a validated, comprehensive questionnaire designed to evaluate patient function and bother after localized prostate cancer treatment. Response options for each item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better quality of life.
Time frame
At 6 weeks, 6 months and 12 months4
Continence rate as measured by 1-hour provocative pad weight test at 6 months post-prostatectomy
Time frame
At 6 months post-prostatectomySponsors and contacts
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Source ClinicalTrials.gov