- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04131907
A Clinical Study to Evaluate the Safety and Efficacy of the Optilume™ BPH Catheter System in Men With Symptomatic BPH (PINNACLE)
October 31, 2022 updated by: Urotronic Inc.
A Prospective, Multicenter, Double Blind, Randomized, Clinical Study to Evaluate the Safety and Efficacy of the Optilume™ BPH Catheter System in Men With Symptomatic BPH
PINNACLE is a prospective, multi-center, randomized control clinical trial to establish the safety and efficacy of the Optilume™ BPH Catheter System in the treatment of benign prostatic hyperplasia (BPH)
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
500
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5G 1E2
- University Urology Associates
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Quebec
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Montreal, Quebec, Canada, H2X 3E4
- University of Montreal Hospital Center (CHUM)
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Arkansas
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Little Rock, Arkansas, United States, 72211
- Arkansas Urology
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Colorado
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Golden, Colorado, United States, 80401
- Colorado Clinical Research
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Florida
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Daytona Beach, Florida, United States, 32114
- Advanced Urology Institute
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Tampa, Florida, United States, 33615
- Florida Urology Partners
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Illinois
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Lake Barrington, Illinois, United States, 60010
- Comprehensive Urologic Care
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Louisiana
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Shreveport, Louisiana, United States, 71106
- Regional Urology, LLC
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Maryland
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Hanover, Maryland, United States, 21076
- Chesapeake Urology Research Associates
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Towson, Maryland, United States, 21204
- Chesapeake Urology Research Associates
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Nevada
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Las Vegas, Nevada, United States, 89144
- Sheldon Freedman MD, Ltd
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New Jersey
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Englewood, New Jersey, United States, 07631
- New Jersey Urology
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New York
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Garden City, New York, United States, 11530
- AccuMed Research Associates
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New York, New York, United States, 10065
- Weill Cornell Medical College
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New York, New York, United States, 10016
- Manhattan Medical Research Practice, PLLC
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North Carolina
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Raleigh, North Carolina, United States, 27612
- Associated Urologists of NC
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South Carolina
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Myrtle Beach, South Carolina, United States, 29572
- Carolina Urologic Research Center
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Texas
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Austin, Texas, United States, 78750
- North Austin Urology
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Austin, Texas, United States, 78745
- Urology Austin, PLLC
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El Paso, Texas, United States, 79912
- Rio Grande Urology
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Webster, Texas, United States, 77598
- Clear Lake Specialties
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
48 years to 78 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Male subject 50-80 years of age who has symptomatic BPH
- International Prostate Symptom Score (IPSS) ≥ 13
- Peak urinary flow rate (Qmax) ≥ 5 ml/sec and ≤ 12 ml/sec (with minimum voided volume of ≥ 150 ml)
- Prostate volume 20 to 80 gm as determined by transrectal ultrasound (TRUS)
- Prostatic urethral length ≥ 32 mm and ≤ 55 mm as determined by TRUS
- History of inadequate response, contraindication, or refusal of BPH medical therapy
- Able to complete the study protocol in the opinion of the investigator
Exclusion Criteria:
- Unable or unwilling to sign the Informed Consent Form (ICF) and/or comply with all the follow-up requirements
- Unwilling to abstain or use protected sex for the first 30 days post treatment
- Unwilling to abstain from sexual intercourse or use a highly effective contraceptive for at least 6 months post-procedure
- Presence of an artificial urinary sphincter or stent(s) in the urethra or prostate
- Any prior minimally invasive intervention (e.g. TUNA, Balloon, Microwave, Rezūm, UroLift) or surgical intervention of the prostate
- Prostate specific antigen (PSA) ≥ 10 ng/ml unless prostate cancer is ruled out by biopsy
- Confirmed or suspected malignancy of prostate or bladder
- Active or history of epididymitis within the past 3 months
- Previous pelvic irradiation or pelvic trauma surgery
- Active urinary tract infection (UTI) confirmed by culture
- Bacterial prostatitis within the last 12 months
- Non-bacterial prostatitis within the last 5 years
- Visible or invisible hematuria (> 4 Red Blood Cells (RBCs) per high power field) on 2 separate urine specimens within the last 3 months without a know contributing factor
- Neurogenic bladder or sphincter abnormalities or neurological disorders that might affect bladder or sphincter function
- History of urinary incontinence
- Previous or current diagnosis of urethral strictures, bladder neck contracture or detrusor muscle spasms
- Previous rectal surgery, other than hemorrhoidectomy
- Use of antihistamines, anticonvulsants or antispasmodics within 1 week prior to baseline assessment unless there is documented evidence of stable dosing for at least 6 months
- Use of antidepressants with adrenergic effects (i.e. duloxetine, imipramine and amitriptyline), long-acting anticholinergics (LAAC) for chronic obstructive pulmonary disease (COPD), or androgens within 2 weeks prior to baseline assessment unless there is documented evidence of stable dosing for at least 3 months prior to baseline assessment
- Use of Luteinizing Hormone-Releasing Hormone (LHRH) analogs within 12 months prior to baseline assessment
- Use of Type II 5-alpha reductase inhibitor [e.g. finasteride (Proscar, Propecia)] within 3 months of baseline assessment
- Use of 5-alpha reductase inhibitor [e.g. dutasteride (Avodart)] within 6 months of baseline assessment
- Use of estrogen or drugs producing androgen suppression unless there is documented evidence of stable dosing for at least 3 months prior to baseline assessment
- Use of alpha blockers or daily dose PDE5 inhibitor (e.g. Cialis) within 2 weeks of baseline assessment
- Use of warfarin or novel oral anti-coagulants [e.g., apixaban (Eliquis), fondaparinux (Arixtra), rivaroxaban (Xarelto) or edoxaban (Savaysa)], unless the medication is safely discontinued prior to the procedure and is not planned to be restarted for at least 5 days post-procedure
- Use of anti-platelet medications (e.g., clopidogrel, aspirin) within 10 days prior to the procedure or planned use within 5 days post-procedure
- History of hypersensitivity reactions to paclitaxel, on medication that may have negative interaction with paclitaxel, presence of solid tumor with a baseline neutrophil count of <1500 cells/mm3 or AIDS-related Kaposi's sarcoma with baseline neutrophil count of <1000 cells/mm3
- Incidence of spontaneous urinary retention within 6 months prior to baseline assessment
- Current post-void residual volume > 300 ml or catheter dependent bladder drainage
- Known poor detrusor muscle function (e.g. Qmax < 5 ml/sec)
- Current bladder or prostatic urethral stones
- Biopsy of prostate within 40 days prior to procedure
- History of cancer in non-genitourinary system which is not considered in complete remission (except basal cell or squamous cell carcinoma of the skin). A potential participant is considered in complete remission if there has been no evidence of cancer within five years
- Current uncontrolled diabetes (i.e. hemoglobin A1c ≥ 8%)
- History of clinically significant comorbidities or presence of unstable conditions [e.g. cardiovascular, lung, renal (serum creatinine > 2.0 mg/dl), hepatic, bleeding disorders or metabolic impairment] that may confound the results of the study or have a risk to subject per investigator's opinion
- Any cognitive disorder that interferes with or precludes direct and accurate communication with the study investigator regarding the study or affects the ability to complete the study quality of life questionnaires
- Life expectancy < 10 years
- Anatomy (e.g. presence of false passage or size of meatus) is not suitable for treatment in this study
- Significant median lobe component [e.g. intravesical prostatic protrusion (IPP) > 1 cm]
- Device that corresponds with the subject's prostate size is not available
- Currently enrolled in or plan to enroll in another investigational clinical study for any disease except for observational only study
- In the opinion of the investigator, it is not in the subject's best interest to participate in the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Optilume™ BPH Catheter System
The Optilume™ BPH, Prostatic Dilation DCB Catheter is a dilation catheter used to exert radial force to dilate the prostatic urethra resulting in a commissurotomy.
The distal end of the catheter has a semi-compliant inflatable double lobe balloon that is coated with a proprietary coating containing the active pharmaceutical paclitaxel.
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The Optilume™ BPH, Prostatic Dilation DCB Catheter is a dilation catheter used to exert radial force to dilate the prostatic urethra resulting in a commissurotomy.
The distal end of the catheter has a semi-compliant inflatable double lobe balloon that is coated with a proprietary coating containing the active pharmaceutical paclitaxel.
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Sham Comparator: Sham Device
The Sham Device is a 21 Fr Optilume BPH, Prostatic Pre-dilation Catheter within the sheath.
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21 Fr sheathed Optilume™ BPH Prostatic Pre-dilation Catheter (modified to prevent inflation)
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Experimental: Pharmacokinetics Optilume Arm
A single arm of 15 non-randomized subjects will be treated in the pharmacokinetics (PK) arm.
These subjects will be treated with the Optilume BPH Catheter System
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The Optilume™ BPH, Prostatic Dilation DCB Catheter is a dilation catheter used to exert radial force to dilate the prostatic urethra resulting in a commissurotomy.
The distal end of the catheter has a semi-compliant inflatable double lobe balloon that is coated with a proprietary coating containing the active pharmaceutical paclitaxel.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in International Prostate Symptom Score (IPSS)
Time Frame: 12 months
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Change in subjects' International Prostate Symptom Score (IPSS) from pre-procedure to 12-months.
The IPSS can be interpreted as follows: 0-7 mildly symptomatic, 8-19 moderately symptomatic, and 20-35 severely symptomatic.
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12 months
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Major Device Related Serious Complications
Time Frame: 12 months
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Rate of major device related serious complications
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12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Steven A Kaplan, MD, Mount Sinai Health System
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 5, 2020
Primary Completion (Actual)
August 23, 2022
Study Completion (Anticipated)
May 1, 2027
Study Registration Dates
First Submitted
October 16, 2019
First Submitted That Met QC Criteria
October 16, 2019
First Posted (Actual)
October 18, 2019
Study Record Updates
Last Update Posted (Actual)
November 1, 2022
Last Update Submitted That Met QC Criteria
October 31, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PR1087
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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