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ProVee Urethral Expander System IDE Study (ProVIDE) (ProVIDE)

Primary Purpose

Benign Prostatic Hyperplasia With Symptomatic Lower Urinary Tract Symptoms

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
ProVee Urethral Expander System
Urethral Access Sheath
Sponsored by
ProVerum Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia With Symptomatic Lower Urinary Tract Symptoms focused on measuring BPH / LUTS

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Males > 45 years of age
  • IPSS of ≥ 13, IPSS V/S > 1 at baseline assessment
  • Prostate volume of ≥ 30 cc and ≤ 80 cc
  • Prostatic urethral L2 lengths ≥ 3.75cm by TRUS
  • Failed, intolerant, or subject choice to not take a medication regimen for the treatment of LUTS

Exclusion Criteria:

  • Void volume <125 ml; Qmax > 12ml/s; PVR > 250 ml
  • Obstructive median lobe (>10mm protrusion on sagittal mid-prostate plane as measured by TRUS)
  • High bladder neck, with the absence of lateral lobe encroachment indicating a high likelihood of primary bladder neck obstruction
  • Known immunosuppression
  • History of or suspected prostate or bladder cancer
  • Baseline PSA > 10 ng/mL or confirmed or suspected prostate cancer (Subjects with a PSA level above 2.5 ng/mL, or age specific, or local reference ranges should have prostate cancer excluded to the Investigator's satisfaction, including a SOC biopsy if indicated).
  • Recent urinary tract stones, within 3 months of index procedure
  • A history of prostatitis within the last two years
  • Active or history of epididymitis within the past 3 months
  • Neurogenic bladder and/or sphincter abnormalities due to Parkinson's disease, multiple sclerosis, cerebral vascular accident
  • History of urinary retention
  • Requiring self-catheterization to void
  • An active urinary tract infection (UTI) at time of index procedure
  • Recent, within 3 months of index procedure, haematuria
  • Subjects with known allergy to nickel or titanium
  • Life expectancy estimated to be less than 60 months
  • Use of estrogen, drug-producing androgen suppression, or anabolic steroids within 3 months of baseline assessment
  • Use of 5-alpha-reductase inhibitors (e.g., dutasteride, finasteride) within 3 months of baseline assessment
  • Use of alpha-blockers (e.g., Terazosin, Doxazosin, Alfuzosin, Tamsulosin) within 2 weeks of baseline assessment
  • Use of androgens (topical are acceptable) and gonadotropin-releasing hormonal analogues, within 2 months of baseline assessment
  • Use of antihistamines, anticonvulsants, and antispasmodics within 1 week of baseline assessment
  • Use of anticholinergics or cholinergic medication within 2 months of baseline assessment
  • Use of beta-blockers where the dose is not stable
  • Use of Phosphodiesterase-5 Enzyme Inhibitors in doses for BPH within 2 weeks of baseline assessment
  • Current treatment with anticoagulants (e.g., coumadin or enoxaparin) or antiplatelet medications other than aspirin (e.g., clopidogrel, or alternative and ASA) where subject is unable to stop taking anticoagulants and/or antiplatelets within 3 days prior to the procedure or coumadin at least 5 days prior to the procedure
  • Future fertility concerns
  • Previous prostate surgery, balloon dilatation, stent implantation, laser prostatectomy, hyperthermia, or any other invasive treatment to the prostate; including penile implants
  • Previous pelvic irradiation or radical pelvic surgery
  • Previous rectal surgery (other than hemorrhoidectomy) or known history of rectal disease
  • Urethral strictures, bladder neck contracture, or other potentially confounding bladder pathology
  • Urethral pathologies that may prevent insertion of Delivery System
  • Uncontrolled diabetes mellitus including Hgb AIC >8%
  • Overactive bladder (OAB) requiring treatment by OAB medication
  • Urinary incontinence
  • Serum creatinine >1.8 mg/dl or upper tract disease)
  • Hepatic disorder, bleeding disorders or metabolic impairment
  • Any major comorbidities or presence of unstable conditions, e.g., uncontrolled HTN, NYHA Class III or IV, cardiac arrhythmias that are not controlled by medication/medical device, myocardial infarction within the past 6 months, COPD with FEV1 <50, renal illness that might prevent study completion or would confound study results
  • Vulnerable populations including institutionalized adults, adults with impaired consent capacity including those with physical, psychological, or medical impairment, prisoners or others who are unable to fully comprehend the study requirements will be excluded from the clinical trial. subjects taking tri-cyclic antidepressants

Sites / Locations

  • Golden State UrologyRecruiting
  • Urological Research Network CorpRecruiting
  • Advanced Urology InstituteRecruiting
  • Tampa Urology LLCRecruiting
  • Avant Concierge UrologyRecruiting
  • Comprehensive Urologic CareRecruiting
  • Southern Illinois University School of MedicineRecruiting
  • Sheldon Freedman MDRecruiting
  • Mount SianiRecruiting
  • Associated Urologists of North CarolinaRecruiting
  • Midtown Urology Assoc.Recruiting
  • Urology AustinRecruiting
  • Urology of VirginiaRecruiting
  • St James's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Sham Comparator

Other

Arm Label

Device: The ProVee Urethral Expander System

Sham: Ureteroscope and urethral access sheath

Crossover ProVee Urethral Expander System

Arm Description

The ProVee Urethral Expander System consists of two components: a nitinol Expander implant and a 19Fr Delivery System designed to allow the Expander to be deployed under direct vision for the treatment arm.

An ureteroscope housed within the inner lumen of an urethral access sheath will be used under direct vision for the Sham procedure.

All subjects shall be unblinded following the 3 month follow-up visit. Those subjects randomized to the Sham Arm will be given the opportunity to "crossover" to the ProVee Urethral Expander System.

Outcomes

Primary Outcome Measures

Safety: Device or Procedure Related Serious Adverse Events
Rate of device or procedure related serious adverse events
Safety: Need for urinary catheterization
The rate of extended post-operative urinary catheterization for inability to void among patients treated with the ProVee device.
Effectiveness: Reduction in BPH Symptoms compared to Sham
The ProVee Treatment Group will be considered superior to the Sham Treatment Group when the mean 3-month improvement from baseline score for the IPSS symptom questionnaire demonstrates a minimum statistical margin of 25% compared to mean improvement from baseline for the Sham Treatment Group alone.
Effectiveness: Symptoms Improvement
The mean percent change in IPSS in the treatment arm is at least 30% improvement over the patient's pre-treatment baseline score.

Secondary Outcome Measures

Full Information

First Posted
December 23, 2021
Last Updated
September 20, 2023
Sponsor
ProVerum Medical
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1. Study Identification

Unique Protocol Identification Number
NCT05186740
Brief Title
ProVee Urethral Expander System IDE Study (ProVIDE)
Acronym
ProVIDE
Official Title
The ProVee Urethral Expander System Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 9, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ProVerum Medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A study to evaluate the safety, performance, and effectiveness of the ProVee Urethral Expander System (Investigational Device) when used in subjects with symptomatic urinary obstruction related to benign prostatic hyperplasia (BPH).
Detailed Description
This is a prospective, multi-center, randomized, single-blind, sham-controlled study to evaluate the safety, performance, and effectiveness of the ProVee Urethral Expander System (Investigational Device) when used in subjects with symptomatic urinary obstruction related to benign prostatic hyperplasia (BPH). Subjects are assigned to their treatment arm using an unbalanced (2 ProVee:1 Sham) randomization stratified by Investigational Sites.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia With Symptomatic Lower Urinary Tract Symptoms
Keywords
BPH / LUTS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, multi-center, randomized, double-blind, sham-controlled safety and effectiveness study
Masking
ParticipantOutcomes Assessor
Masking Description
Subject will have noise cancelling headphones on during the treatment. A drape will be placed preventing subjects from observing implant procedure. The follow-up clinic coordinator will not have access to enrolled subjects' medical records including the randomization scheme and treatment procedure.
Allocation
Randomized
Enrollment
225 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Device: The ProVee Urethral Expander System
Arm Type
Active Comparator
Arm Description
The ProVee Urethral Expander System consists of two components: a nitinol Expander implant and a 19Fr Delivery System designed to allow the Expander to be deployed under direct vision for the treatment arm.
Arm Title
Sham: Ureteroscope and urethral access sheath
Arm Type
Sham Comparator
Arm Description
An ureteroscope housed within the inner lumen of an urethral access sheath will be used under direct vision for the Sham procedure.
Arm Title
Crossover ProVee Urethral Expander System
Arm Type
Other
Arm Description
All subjects shall be unblinded following the 3 month follow-up visit. Those subjects randomized to the Sham Arm will be given the opportunity to "crossover" to the ProVee Urethral Expander System.
Intervention Type
Device
Intervention Name(s)
ProVee Urethral Expander System
Other Intervention Name(s)
ProVee Expander, ProVee
Intervention Description
ProVee Expander is placed in prostatic urethra to relieve obstruction due to BPH.
Intervention Type
Procedure
Intervention Name(s)
Urethral Access Sheath
Intervention Description
The Urethral Access Sheath is introduced into the prostatic urethra to simulate the placement of the ProVee Expander.
Primary Outcome Measure Information:
Title
Safety: Device or Procedure Related Serious Adverse Events
Description
Rate of device or procedure related serious adverse events
Time Frame
Procedure - 12 months
Title
Safety: Need for urinary catheterization
Description
The rate of extended post-operative urinary catheterization for inability to void among patients treated with the ProVee device.
Time Frame
> 7 days from treatment - 12 months
Title
Effectiveness: Reduction in BPH Symptoms compared to Sham
Description
The ProVee Treatment Group will be considered superior to the Sham Treatment Group when the mean 3-month improvement from baseline score for the IPSS symptom questionnaire demonstrates a minimum statistical margin of 25% compared to mean improvement from baseline for the Sham Treatment Group alone.
Time Frame
Procedure to 3 months
Title
Effectiveness: Symptoms Improvement
Description
The mean percent change in IPSS in the treatment arm is at least 30% improvement over the patient's pre-treatment baseline score.
Time Frame
Procedure to 12 months

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Male
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Males > 45 years of age IPSS of ≥ 13, IPSS V/S > 1 at baseline assessment Prostate volume of ≥ 30 cc and ≤ 80 cc Prostatic urethral L2 lengths ≥ 3.75cm by TRUS Failed, intolerant, or subject choice to not take a medication regimen for the treatment of LUTS Exclusion Criteria: Void volume <125 ml; Qmax > 12ml/s; PVR > 250 ml Obstructive median lobe defined by EITHER (>10mm protrusion on sagittal mid-prostate plane as measured by TRUS) OR an obstructive median lobe seen on cystoscopy e.g., 'ball valve'' High bladder neck, with the absence of lateral lobe encroachment indicating a high likelihood of primary bladder neck obstruction Anatomy that would prevent the apices of the ProVee from engaging with the lateral lobes e.g., high degree of bladder neck angulation such that the anterior bladder neck is not visible Acute urinary retention Known immunosuppression History of or suspected prostate or bladder cancer Baseline PSA > 10 ng/mL or confirmed or suspected prostate cancer (Subjects with a PSA level above 2.5 ng/mL, or age specific, or local reference ranges should have prostate cancer excluded to the Investigator's satisfaction, including a SOC biopsy if indicated). Recent urinary tract stones, OR widespread calcifications on the prostatic urethral wall, within 3 months of index procedure A history of prostatitis within the last two years Active or history of epididymitis within the past 3 months Neurogenic bladder and/or sphincter abnormalities due to Parkinson's disease, multiple sclerosis, cerebral vascular accident History of urinary retention within 12 months of baseline assessment Requiring self-catheterization to void An active urinary tract infection (UTI) at time of index procedure Gross haematuria, within 3 months of index procedure, haematuria Subjects with known allergy to nickel or titanium Life expectancy estimated to be less than 60 months Use of estrogen, drug-producing androgen suppression, or anabolic steroids (topical/ nasal acceptable) within 1 year of baseline assessment Use of 5-alpha-reductase inhibitors (e.g., dutasteride, finasteride) within 6 months of baseline assessment Use of Phenylephrine / Pseudoephedrine within 24 hours of baseline assessment Use of alpha-blockers (e.g., Terazosin, Doxazosin, Alfuzosin, Tamsulosin) within 2 weeks of baseline assessment Use of gonadotropin-releasing hormonal analogues, within 2 months of baseline assessment Use of antihistamines, anticonvulsants, and antispasmodics within 1 week of baseline assessment Use of anticholinergics or cholinergic medication within 2 weeks of baseline assessment Use of beta-blockers where the dose is not stable Use of Phosphodiesterase-5 Enzyme Inhibitors in doses for BPH within 2 weeks of baseline assessment Current treatment with anticoagulants (e.g., coumadin or enoxaparin) or antiplatelet medications other than aspirin (e.g., clopidogrel, or alternative and ASA) where subject is unable to stop taking anticoagulants and/or antiplatelets within 3 days prior to the procedure or coumadin at least 5 days prior to the procedure Future fertility concerns Previous prostate surgery, balloon dilatation, stent implantation, laser prostatectomy, hyperthermia, or any other invasive treatment to the prostate; including penile implants Previous pelvic irradiation or radical pelvic surgery Previous rectal surgery (other than hemorrhoidectomy) or known history of rectal disease Urethral strictures, bladder neck contracture, or other potentially confounding bladder pathology Urethral pathologies that may prevent insertion of Delivery System Uncontrolled diabetes mellitus including Hgb AIC >8% Overactive bladder (OAB) requiring treatment by OAB medication Urinary incontinence Serum creatinine >1.8 mg/dl or upper tract disease) Hepatic disorder, bleeding disorders or metabolic impairment Any major comorbidities or presence of unstable conditions, e.g., uncontrolled HTN, NYHA Class III or IV, cardiac arrhythmias that are not controlled by medication/medical device, myocardial infarction within the past 6 months, COPD with FEV1 <50, renal illness that might prevent study completion or would confound study results Vulnerable populations including institutionalized adults, adults with impaired consent capacity including those with physical, psychological, or medical impairment, prisoners or others who are unable to fully comprehend the study requirements will be excluded from the clinical trial. subjects taking tri-cyclic antidepressants
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Diane Gargus, MSc. FNP
Phone
1-720-472-1504
Email
diane@proverummedical.com
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Lyon, PhD
Phone
1-720-938-9961
Email
michael.lyon@proverummedical.com
Facility Information:
Facility Name
Golden State Urology
City
Sacramento
State/Province
California
ZIP/Postal Code
95823
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prithipal Sethi
Facility Name
Urological Research Network Corp
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edward Gheiler
Facility Name
Advanced Urology Institute
City
Palm Coast
State/Province
Florida
ZIP/Postal Code
32164
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samuel Lawindy
Facility Name
Tampa Urology LLC
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raviender Bukkapatnam
Facility Name
Avant Concierge Urology
City
Winter Garden
State/Province
Florida
ZIP/Postal Code
34787
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sijo Parekattil
Facility Name
Comprehensive Urologic Care
City
Lake Barrington
State/Province
Illinois
ZIP/Postal Code
60010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ning Wu
Facility Name
Southern Illinois University School of Medicine
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicholas Tadros
Facility Name
Sheldon Freedman MD
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89144
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sheldon Freedman
Facility Name
Mount Siani
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dhruti Patel
Facility Name
Associated Urologists of North Carolina
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Jalkut
Facility Name
Midtown Urology Assoc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Trotter
Facility Name
Urology Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Mazzarella
Facility Name
Urology of Virginia
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23462
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gregg Eure
Facility Name
St James's Hospital
City
Dublin
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barry Jones

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.proverummedical.com/
Description
ProVerum Website

Learn more about this trial

ProVee Urethral Expander System IDE Study (ProVIDE)

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