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A Clinical Study to Evaluate the Safety and Efficacy of the Optilume™ BPH Catheter System in Men With Symptomatic BPH (PINNACLE)

Primary Purpose

Benign Prostatic Hyperplasia

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Optilume BPH Catheter System
Optilume Sham Device
Sponsored by
Urotronic Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia focused on measuring BPH, Drug Coated Balloon, DCB, prostate, LUTS, Optilume

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male subject 50-80 years of age who has symptomatic BPH
  2. International Prostate Symptom Score (IPSS) ≥ 13
  3. Peak urinary flow rate (Qmax) ≥ 5 ml/sec and ≤ 12 ml/sec (with minimum voided volume of ≥ 150 ml)
  4. Prostate volume 20 to 80 gm as determined by transrectal ultrasound (TRUS)
  5. Prostatic urethral length ≥ 32 mm and ≤ 55 mm as determined by TRUS
  6. History of inadequate response, contraindication, or refusal of BPH medical therapy
  7. Able to complete the study protocol in the opinion of the investigator

Exclusion Criteria:

  1. Unable or unwilling to sign the Informed Consent Form (ICF) and/or comply with all the follow-up requirements
  2. Unwilling to abstain or use protected sex for the first 30 days post treatment
  3. Unwilling to abstain from sexual intercourse or use a highly effective contraceptive for at least 6 months post-procedure
  4. Presence of an artificial urinary sphincter or stent(s) in the urethra or prostate
  5. Any prior minimally invasive intervention (e.g. TUNA, Balloon, Microwave, Rezūm, UroLift) or surgical intervention of the prostate
  6. Prostate specific antigen (PSA) ≥ 10 ng/ml unless prostate cancer is ruled out by biopsy
  7. Confirmed or suspected malignancy of prostate or bladder
  8. Active or history of epididymitis within the past 3 months
  9. Previous pelvic irradiation or pelvic trauma surgery
  10. Active urinary tract infection (UTI) confirmed by culture
  11. Bacterial prostatitis within the last 12 months
  12. Non-bacterial prostatitis within the last 5 years
  13. 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
  14. Neurogenic bladder or sphincter abnormalities or neurological disorders that might affect bladder or sphincter function
  15. History of urinary incontinence
  16. Previous or current diagnosis of urethral strictures, bladder neck contracture or detrusor muscle spasms
  17. Previous rectal surgery, other than hemorrhoidectomy
  18. 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
  19. 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
  20. Use of Luteinizing Hormone-Releasing Hormone (LHRH) analogs within 12 months prior to baseline assessment
  21. Use of Type II 5-alpha reductase inhibitor [e.g. finasteride (Proscar, Propecia)] within 3 months of baseline assessment
  22. Use of 5-alpha reductase inhibitor [e.g. dutasteride (Avodart)] within 6 months of baseline assessment
  23. 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
  24. Use of alpha blockers or daily dose PDE5 inhibitor (e.g. Cialis) within 2 weeks of baseline assessment
  25. 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
  26. Use of anti-platelet medications (e.g., clopidogrel, aspirin) within 10 days prior to the procedure or planned use within 5 days post-procedure
  27. 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
  28. Incidence of spontaneous urinary retention within 6 months prior to baseline assessment
  29. Current post-void residual volume > 300 ml or catheter dependent bladder drainage
  30. Known poor detrusor muscle function (e.g. Qmax < 5 ml/sec)
  31. Current bladder or prostatic urethral stones
  32. Biopsy of prostate within 40 days prior to procedure
  33. 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
  34. Current uncontrolled diabetes (i.e. hemoglobin A1c ≥ 8%)
  35. 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
  36. 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
  37. Life expectancy < 10 years
  38. Anatomy (e.g. presence of false passage or size of meatus) is not suitable for treatment in this study
  39. Significant median lobe component [e.g. intravesical prostatic protrusion (IPP) > 1 cm]
  40. Device that corresponds with the subject's prostate size is not available
  41. Currently enrolled in or plan to enroll in another investigational clinical study for any disease except for observational only study
  42. In the opinion of the investigator, it is not in the subject's best interest to participate in the study

Sites / Locations

  • Arkansas Urology
  • Colorado Clinical Research
  • Advanced Urology Institute
  • Florida Urology Partners
  • Comprehensive Urologic Care
  • Regional Urology, LLC
  • Chesapeake Urology Research Associates
  • Chesapeake Urology Research Associates
  • Sheldon Freedman MD, Ltd
  • New Jersey Urology
  • AccuMed Research Associates
  • Manhattan Medical Research Practice, PLLC
  • Weill Cornell Medical College
  • Associated Urologists of NC
  • Carolina Urologic Research Center
  • Urology Austin, PLLC
  • North Austin Urology
  • Rio Grande Urology
  • Clear Lake Specialties
  • University Urology Associates
  • University of Montreal Hospital Center (CHUM)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Experimental

Arm Label

Optilume™ BPH Catheter System

Sham Device

Pharmacokinetics Optilume Arm

Arm Description

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.

The Sham Device is a 21 Fr Optilume BPH, Prostatic Pre-dilation Catheter within the sheath.

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

Outcomes

Primary Outcome Measures

Change in International Prostate Symptom Score (IPSS)
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.
Major Device Related Serious Complications
Rate of major device related serious complications

Secondary Outcome Measures

Full Information

First Posted
October 16, 2019
Last Updated
October 31, 2022
Sponsor
Urotronic Inc.
Collaborators
ClinLogix. LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04131907
Brief Title
A Clinical Study to Evaluate the Safety and Efficacy of the Optilume™ BPH Catheter System in Men With Symptomatic BPH
Acronym
PINNACLE
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 5, 2020 (Actual)
Primary Completion Date
August 23, 2022 (Actual)
Study Completion Date
May 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Urotronic Inc.
Collaborators
ClinLogix. LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia
Keywords
BPH, Drug Coated Balloon, DCB, prostate, LUTS, Optilume

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized study with a non-randomized, Pharmacokinetics arm. Subjects randomized to the Control arm are allowed to crossover to the Test arm if they meet the eligibility criteria after completing the 3-Month Follow-up Visit and prior to the close of the 12-Month visit window. Up to 625 subjects will be enrolled (i.e. consented) in the study in order to identify 162 eligible subjects (147 randomized subjects and 15 Pharmacokinetic subjects)
Masking
ParticipantOutcomes Assessor
Masking Description
Subjects in the Randomization arm of the study are randomized in a 2:1 allocation of Test to Control. The treating physician is unblinded to the treatment assignment. A blinded person at the study site conducts all study follow-up visits through the 12-Month follow-up visit (or until the subject is unblinded). The subject may be unblinded prior to the 12-Month visit if it is medically necessary, which includes the subject seeking alternative BPH therapy due to continued or recurrent BPH symptoms.
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Optilume™ BPH Catheter System
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham Device
Arm Type
Sham Comparator
Arm Description
The Sham Device is a 21 Fr Optilume BPH, Prostatic Pre-dilation Catheter within the sheath.
Arm Title
Pharmacokinetics Optilume Arm
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Optilume BPH Catheter System
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Optilume Sham Device
Intervention Description
21 Fr sheathed Optilume™ BPH Prostatic Pre-dilation Catheter (modified to prevent inflation)
Primary Outcome Measure Information:
Title
Change in International Prostate Symptom Score (IPSS)
Description
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.
Time Frame
12 months
Title
Major Device Related Serious Complications
Description
Rate of major device related serious complications
Time Frame
12 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven A Kaplan, MD
Organizational Affiliation
Mount Sinai Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arkansas Urology
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Colorado Clinical Research
City
Golden
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States
Facility Name
Advanced Urology Institute
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32114
Country
United States
Facility Name
Florida Urology Partners
City
Tampa
State/Province
Florida
ZIP/Postal Code
33615
Country
United States
Facility Name
Comprehensive Urologic Care
City
Lake Barrington
State/Province
Illinois
ZIP/Postal Code
60010
Country
United States
Facility Name
Regional Urology, LLC
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71106
Country
United States
Facility Name
Chesapeake Urology Research Associates
City
Hanover
State/Province
Maryland
ZIP/Postal Code
21076
Country
United States
Facility Name
Chesapeake Urology Research Associates
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Sheldon Freedman MD, Ltd
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89144
Country
United States
Facility Name
New Jersey Urology
City
Englewood
State/Province
New Jersey
ZIP/Postal Code
07631
Country
United States
Facility Name
AccuMed Research Associates
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Facility Name
Manhattan Medical Research Practice, PLLC
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Associated Urologists of NC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Carolina Urologic Research Center
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
Urology Austin, PLLC
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
North Austin Urology
City
Austin
State/Province
Texas
ZIP/Postal Code
78750
Country
United States
Facility Name
Rio Grande Urology
City
El Paso
State/Province
Texas
ZIP/Postal Code
79912
Country
United States
Facility Name
Clear Lake Specialties
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
University Urology Associates
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1E2
Country
Canada
Facility Name
University of Montreal Hospital Center (CHUM)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 3E4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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A Clinical Study to Evaluate the Safety and Efficacy of the Optilume™ BPH Catheter System in Men With Symptomatic BPH

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