Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter (EVEREST-I)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03423979
Recruitment Status : Active, not recruiting
First Posted : February 6, 2018
Last Update Posted : March 27, 2019
Sponsor:
Information provided by (Responsible Party):
Urotronic Inc.

Brief Summary:

A prospective, non-randomized study. The subjects will be enrolled and treated with the Optilume BPH Prostatic DCB Dilation Catheter System at up to 8 clinical sites. The post-treatment follow-up visit can be up to 5 years.

The objective of the study is to evaluate the safety and efficacy of the Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter System in the treatment of BPH.


Condition or disease Intervention/treatment Phase
Benign Prostatic Hyperplasia Benign Prostatic Hypertrophy Device: Optilume™ BPH Prostatic DCB Dilation Catheter Drug: Paclitaxel Phase 2

Detailed Description:

A prospective, non-randomized, multi-center study. The study will enroll up to 85 subjects to be enrolled and treated with the Optilume BPH Prostatic DCB Dilation Catheter System at up to 8 clinical sites. Subjects will be followed up post-treatment at Foley removal, and up to 1 year. The subjects may choose to be followed-up annually for 5 years or until study close, whichever comes first.

Study device is Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter System.

Study primarily outcomes are measured by 1). Change in IPSS score at 3-month post-procedure follow-up; 2). Major device or procedure related complications at 3-month post-procedure follow-up.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 85 participants
Intervention Model: Single Group Assignment
Intervention Model Description: treatment group - treated with Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter in the Treatment of Moderate-to-Severe Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia
Actual Study Start Date : December 19, 2017
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 30, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

Arm Intervention/treatment
Experimental: Optilume™ BPH Prostatic DCB Dilation Catheter
Optilume™ BPH Prostatic DCB treatment procedure
Device: Optilume™ BPH Prostatic DCB Dilation Catheter
BPH Prostatic DCB treatment - The Optilume BPH Prostatic DCB Dilation Catheter System should be prepared per the Instructions for Use (IFU).
Other Name: BPH Prostatic DCB

Drug: Paclitaxel
paclitaxel will release to adjacent tissue after the balloon inflated in the urethra
Other Name: drug coated balloon




Primary Outcome Measures :
  1. To assess the performance of the Optilume BPH Prostatic DCB Dilation Catheter by changing in BPH score before and after the treatment [ Time Frame: 90 days ]
    Change in IPSS (BPH) score is measured by the change of mean IPSS scores between the baseline and 3 months post-procedure.

  2. To evaluate the safety of the Optilume BPH Prostatic DCB Dilation Catheter System in the treatment of LUTS/BPH by occurrence of study device/ procedure related adverse event [ Time Frame: 90 days ]
    Major Device or Procedure Related Complications at 3 Months post-procedure



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Based on biological sex
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male subject > 50 years of age who has moderate-to-severe LUTS (IPSS score of ≥ 13) and is a candidate for interventional therapy
  2. LUTS felt to be secondary to an enlarged prostate (henceforth termed LUTS/BPH)
  3. Peak urinary flow rate (Qmax) ≥ 5 mL/sec and ≤ 15 ml/sec with minimum voided volume of ≥ 125 ml
  4. Post-void residual (PVR) ≤ 250 ml
  5. Prostate volume 20 - 80 gm as determined by TRUS
  6. Prostatic urethra length is 35 - 55 mm as determined by TRUS
  7. Able to complete the study protocol in the opinion of the investigator

Exclusion Criteria:

  1. Interested in maintaining fertility and unwilling to use protected sex for the first 30 days post treatment
  2. Unwilling to abstain or use protected sex for ninety (90) days post treatment if sexual partner is of child bearing potential
  3. Presence of a penile implant or stent(s) in the urethra or prostate
  4. Any prior minimally invasive intervention (e.g. TUNA, Balloon, Microwave, Rezūm, UroLift) or surgical intervention of the prostate
  5. PSA > 10 ng/ml unless prostate cancer is ruled out by biopsy. If PSA is > 4 ng/ml and ≤ 10 ng/ml, prostate cancer must be ruled out to the satisfaction of the investigator via additional tests including digital rectal exam (DRE) and/or biopsy
  6. Confirmed or suspected malignancy of prostate or bladder
  7. Active or history of epididymitis within the past 3 months
  8. Previous pelvic irradiation or radical pelvic surgery
  9. Documented active urinary tract infection (UTI) by culture or bacterial prostatitis within last year documented by culture (UTI is defined as >100,000 colonies per ml urine from midstream clean catch or catheterization specimen)
  10. Visible hematuria with subject urine sample without known contributing factor
  11. Neurogenic bladder or sphincter abnormalities or neurological disorders that might affect bladder or sphincter function
  12. Previous or current diagnosis of urethral strictures, bladder neck contracture or detrusor muscle spasms
  13. Use of beta blockers, antihistamines, anticonvulsants, or antispasmodics within 1 week prior to treatment unless there is documented evidence of stable dosing for last 6 months (no dose changes)
  14. Use of alpha blockers, antidepressants, anticholinergics, androgens, daily tadalafil or gonadotropin-releasing hormonal analogs (prescribed for BPH) within 3 weeks prior to treatment
  15. Use of 5-alpha reductase inhibitor within 6 months prior to treatment
  16. Incidence of spontaneous urinary retention within 6 months prior to baseline assessment
  17. Post-void residual volume > 250 ml or catheter dependent bladder drainage
  18. Overactive bladder (OAB) or urge incontinence
  19. Known poor detrusor muscle function (e.g. Qmax < 5 ml/sec)
  20. Current bladder stones or prostatic calculi
  21. Biopsy of prostate within 30 days prior to procedure or planned within 30 days following the procedure
  22. History of cancer in non-genitourinary system which is not considered cured (except basal cell or squamous cell carcinoma of the skin). A potential participant is considered cured if there has been no evidence of cancer within five years
  23. 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
  24. 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
  25. Expected life expectancy < one year
  26. Unable or unwilling to sign the Informed Consent Form (ICF) and/or comply with all the follow-up requirements
  27. Currently enrolled in or plan to enroll in another investigational clinical trial for any disease except for observational only study
  28. In the opinion of the investigator, it is not in the subject's best interest to participate in the study
  29. Current treatment with anti-coagulants (e.g., warfarin or enoxaparin) or anti-platelet medications other than aspirin (e.g., clopidogrel)
  30. Anatomy, e.g. presence of false passage or size of meatus, is not suitable for treatment in this study
  31. Device that corresponds with the subject's prostate size per the IFU is not available
  32. Intravesical prostatic protrusion (IPP) > 1 cm
  33. Current uncontrolled diabetes (hemoglobin A1c > 7%)
  34. Unable or unwilling to provide all the protocol-required semen samples
  35. Sensitivity to paclitaxel, on medication that may have negative interaction with paclitaxel, or contraindicated for systemic paclitaxel

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): NCT03423979


Locations
Layout table for location information
Dominican Republic
Union Medica Hospital
Santiago De Los Caballeros, Santiago, Dominican Republic
Urolaser SRL
Santo Domingo Oeste, Santo Domingo, Dominican Republic
Urolaser
Santo Domingo Oeste, Santo Domingo, Dominican Republic
Centro Medico Dr. Canela, SRL
La Romana, Dominican Republic
Panama
Consultorios Royal Center
Panama City,, Urbanización Marbella Ciudad De Panamá, Panama
Centro Especializado San Fernando
Ciudad de Panamá, Panama
Sponsors and Collaborators
Urotronic Inc.
Investigators
Layout table for investigator information
Study Director: Jill Moland Urotronic Inc.

Layout table for additonal information
Responsible Party: Urotronic Inc.
ClinicalTrials.gov Identifier: NCT03423979     History of Changes
Other Study ID Numbers: PR1051
First Posted: February 6, 2018    Key Record Dates
Last Update Posted: March 27, 2019
Last Verified: March 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Urotronic Inc.:
BPH
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Hyperplasia
Hyperplasia
Hypertrophy
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Pathological Conditions, Anatomical
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action