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Device
Optilume™ BPH Catheter System for Enlarged Prostate (PINNACLE Trial)
N/A
Waitlist Available
Led By Steven A Kaplan, MD
Research Sponsored by Urotronic Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Prostatic urethral length ≥ 32 mm and ≤ 55 mm as determined by TRUS
Male subject 50-80 years of age who has symptomatic BPH
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
PINNACLE Trial Summary
This trial is testing a new device to treat BPH and establish if it is safe and effective.
Who is the study for?
Men aged 50-80 with symptomatic BPH, having a prostate size of 20 to 80 gm and specific urinary flow rates. They must have had an inadequate response or contraindication to BPH medical therapy. Exclusions include those with certain prostate conditions, recent use of specific drugs, history of hypersensitivity reactions to paclitaxel, confirmed malignancies, uncontrolled diabetes, and more.Check my eligibility
What is being tested?
The PINNACLE trial is testing the Optilume™ BPH Catheter System against a sham device in men with benign prostatic hyperplasia (BPH). It's designed to see if this system is safe and effective for treating symptoms associated with an enlarged prostate.See study design
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects may include discomfort or pain at the catheter insertion site, urinary tract infections (UTI), bleeding or irritation within the urethra or bladder due to device usage.
PINNACLE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My prostate urethra length is between 32 mm and 55 mm.
Select...
I am a man aged 50-80 with symptoms of an enlarged prostate.
Select...
My urine flow rate is between 5 and 12 ml/sec.
PINNACLE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in International Prostate Symptom Score (IPSS)
Major Device Related Serious Complications
PINNACLE Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Pharmacokinetics Optilume ArmExperimental Treatment1 Intervention
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
Group II: Optilume™ BPH Catheter SystemExperimental Treatment1 Intervention
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.
Group III: Sham DevicePlacebo Group1 Intervention
The Sham Device is a 21 Fr Optilume BPH, Prostatic Pre-dilation Catheter within the sheath.
Find a Location
Who is running the clinical trial?
Urotronic Inc.Lead Sponsor
8 Previous Clinical Trials
432 Total Patients Enrolled
ClinLogix. LLCIndustry Sponsor
10 Previous Clinical Trials
1,205 Total Patients Enrolled
Steven A Kaplan, MDPrincipal InvestigatorMount Sinai Health System
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any major health issues that could affect the study.I have not used 5-alpha reductase inhibitors like Avodart in the last 6 months.I have had blood in my urine twice in the last 3 months without a clear reason.I have had cancer outside the urinary system, not in complete remission, except for skin cancer.My bladder muscle is weak.I have had non-bacterial prostatitis in the last 5 years.My prostate has a significant growth into my bladder.My prostate size is between 20 to 80 grams as measured by ultrasound.I have had epididymitis in the last 3 months.I have had radiation or surgery for a pelvic injury.I have an artificial device in my urinary system.I have had a bacterial infection in my prostate in the last year.I agree to use protection or abstain from sex for 30 days after treatment.I have had rectal surgery, but not for hemorrhoids.I have not had sudden inability to urinate in the last 6 months.I have had issues with my bladder or urethra, like strictures or spasms.I have been on a stable dose of estrogen or androgen suppression drugs for at least 3 months.I am not currently using blood thinners or can stop them safely before and after the procedure.I am allergic to paclitaxel, take medication that interacts with it, or have low neutrophil counts.I currently have a UTI confirmed by a lab test.My prostate urethra length is between 32 mm and 55 mm.I have tried BPH medication without success, cannot take it, or have chosen not to.I haven't taken any blood-thinning medications like aspirin in the last 10 days.I have or might have prostate or bladder cancer.I have a condition affecting my bladder or its control due to nerve issues.I have been on stable doses of certain antidepressants, COPD medication, or androgens for over 3 months.My anatomy is not suitable for the study's treatment.I cannot avoid sex or use effective birth control for 6 months after the procedure.I can communicate clearly and complete questionnaires without any cognitive issues.I have used LHRH analogs in the last 12 months.I am a man aged 50-80 with symptoms of an enlarged prostate.My urine flow rate is between 5 and 12 ml/sec.I have a history of not being able to control my urination.You have a life expectancy of less than 10 years.I have been on a stable dose of antihistamines, anticonvulsants, or antispasmodics for at least 6 months.I have had a procedure or surgery on my prostate.I haven't taken alpha blockers or PDE5 inhibitors like Cialis in the last 2 weeks.My PSA level is 10 ng/ml or higher, but prostate cancer has been ruled out.I haven't taken drugs like finasteride in the last 3 months.I have stones in my bladder or prostatic urethra.My diabetes is not under control (A1c is 8% or higher).
Research Study Groups:
This trial has the following groups:- Group 1: Sham Device
- Group 2: Optilume™ BPH Catheter System
- Group 3: Pharmacokinetics Optilume Arm
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Enlarged Prostate Patient Testimony for trial: Trial Name: NCT04131907 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What criteria must be fulfilled to participate in this clinical trial?
"This trial is seeking 500 participants aged 50 to 80 who present with hyperplasia and meet certain criteria, including an International Prostate Symptom Score (IPSS) of at least 13, a Peak urinary flow rate between 5 ml/sec and 12 ml/sec when the voided volume is 150ml or more, as well as a documented reluctance to receive medical therapy for BPH."
Answered by AI
Does this research effort include elderly participants in its enrollment?
"For entry into this clinical trial, patients must be aged between 50 to 80 years old. However, there are 28 studies for those under 18 and 105 trials suited for seniors above 65."
Answered by AI
To what extent is this experiment being conducted at healthcare centers?
"Manhattan Medical Research Practice, PLLC in New york City; AccuMed Research Associates in Garden City; and Carolina Urologic Research Center in Myrtle Beach are just a few of the 10 sites currently participating."
Answered by AI
Are there any open enrollment opportunities for this trial?
"Clinicaltrials.gov reports that recruitment for this study has ceased, as it was initially posted on February 5th 2020 and last modified on October 31st 2022. For those seeking to participate in a similar trial, there are currently 137 other trials actively enrolling patients at present."
Answered by AI
Who else is applying?
What state do they live in?
New Jersey
Nevada
What site did they apply to?
New Jersey Urology
Associated Urologists of NC
Other
Sheldon Freedman MD, Ltd
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
3+
Why did patients apply to this trial?
I am interested in any process that will improve my prostate situation.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
How often would I have to travel to trial site and what accommodations would be required?
PatientReceived no prior treatments
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