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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)

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ClinicalTrials.gov Identifier: NCT04131907
Recruitment Status : Active, not recruiting
First Posted : October 18, 2019
Last Update Posted : November 1, 2022
Sponsor:
Collaborator:
ClinLogix. LLC
Information provided by (Responsible Party):
Urotronic Inc.

Study Description
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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)

Condition or disease Intervention/treatment Phase
Benign Prostatic Hyperplasia Device: Optilume BPH Catheter System Device: Optilume Sham Device Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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: Double (Participant, Outcomes 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.
Primary Purpose: Treatment
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
Actual Study Start Date : February 5, 2020
Actual Primary Completion Date : August 23, 2022
Estimated Study Completion Date : May 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 Device: 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.
Sham Comparator: Sham Device
The Sham Device is a 21 Fr Optilume BPH, Prostatic Pre-dilation Catheter within the sheath.
 Device: Optilume Sham Device
21 Fr sheathed Optilume™ BPH Prostatic Pre-dilation Catheter (modified to prevent inflation)
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
 Device: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in International Prostate Symptom Score (IPSS) [ Time Frame: 12 months ]
    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.

  2. Major Device Related Serious Complications [ Time Frame: 12 months ]
    Rate of major device related serious complications


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04131907


Locations
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Sponsors and Collaborators
Urotronic Inc.
ClinLogix. LLC
Investigators
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Principal Investigator: Steven A Kaplan, MD Mount Sinai Health System
More Information
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Responsible Party: Urotronic Inc.
ClinicalTrials.gov Identifier: NCT04131907    
Other Study ID Numbers: PR1087
First Posted: October 18, 2019    Key Record Dates
Last Update Posted: November 1, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Urotronic Inc.:
BPH, Drug Coated Balloon, DCB, prostate, LUTS, Optilume
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Hyperplasia
Pathologic Processes
Prostatic Diseases
 Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Male Urogenital Diseases