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Optilume BPH Catheter System in Benign Prostatic Hyperplasia (BPH) (SUMMIT)

Primary Purpose

Benign Prostatic Hyperplasia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Optilume Catheter System
Sponsored by
Dean Elterman
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia focused on measuring Optilume, MIST

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male subject with symptomatic BPH NOTE: Symptomatic BPH is defined as an International Prostate Symptom Score (IPSS) ≥ 13 and peak urinary flow rate (Qmax) of ≤15 mL/sec
  2. Prostate dimensions suitable for treatment with the Optilume BPH Catheter System in accordance with the approved Instructions for Use NOTE: Prostate volume between 20 to 80 gm and prostatic urethral length between 32 mm and 55 mm as determined by TRUS
  3. 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 follow-up requirements
  2. Unwilling to abstain from sexual intercourse or use a condom for 30 days post-procedure and a highly effective contraceptive for at least 6 months post-procedure
  3. Presence of an artificial urinary sphincter 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. Confirmed or suspected malignancy of prostate or bladder
  6. Active urinary tract infection (UTI) confirmed by culture
  7. History of overt urinary incontinence requiring use of pads NOTE: Pad usage for post-micturition dribble is acceptable
  8. Presence of confounding diagnoses impacting lower urinary tract symptoms or bladder function (e.g. urethral strictures, bladder neck contracture, neurogenic bladder, detrusor instability, bladder stones, etc.)
  9. History of chronic urinary retention (e.g. PVR ≥300mL on two separate occasions, or catheter dependent drainage)
  10. Anatomy (e.g. presence of false passage or size of meatus) is not suitable for treatment with the Optilume BPH Catheter System
  11. Significant obstruction from median lobe in the opinion of the investigator
  12. Disease or other health condition that is not suitable for this study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Treatment

    Arm Description

    Optilume Catheter System

    Outcomes

    Primary Outcome Measures

    Efficacy: Responder Rate at 12 months
    ≥30% improvement in International Prostate Symptom Score (IPSS) score without the need of an additional surgical or minimally invasive procedure. IPSS score ranges from 0-35 (higher score means worse symptoms)
    Safety (adverse events)
    Frequency and severity of treatment related adverse events will be reported using the Clavien-Dindo severity grading system.

    Secondary Outcome Measures

    Change in IPSS & IPSS QoL (questionnaire)
    IPSS & IPSS QoL questionnaire
    Change in Qmax (maximum flow rate)
    Uroflow to measure maximum flow rate
    Change in PVR (post-void residual)
    Bladder scanner to measure post-void residual
    Change in sexual function (International Index of Erectile Function, IIEF questionnaire)
    IIEF questionnaire. Lower score in IIEF means worse in erectile dysfunction.
    Change in sexual function (Male Sexual Health Questionnaire ejaculatory dysfunction, MSHQ-EjD questionnaire)
    MSHQ-EjD questionnaire. Lower score in MSHQ-EjD means worse in ejaculation function.
    Quality of Recovery (QoR) Visual Analogue Scale (VAS) score at 30 days.
    QoR VAS questionnaire. Higher score means good in recovery.
    Health care usage
    Procedure time
    Health care usage
    Readmission rate within 30days
    Rate of repeat surgical intervention
    Number of participants that need repeated surgical intervention

    Full Information

    First Posted
    September 29, 2022
    Last Updated
    September 30, 2022
    Sponsor
    Dean Elterman
    Collaborators
    Urotronic Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05567666
    Brief Title
    Optilume BPH Catheter System in Benign Prostatic Hyperplasia (BPH)
    Acronym
    SUMMIT
    Official Title
    A Real-word, Clinical Study to Evaluate the Performance of the Optilume® BPH Catheter System in Men With Symptomatic Benign Prostatic Hyperplasia (BPH)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 15, 2022 (Anticipated)
    Primary Completion Date
    December 31, 2024 (Anticipated)
    Study Completion Date
    December 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Dean Elterman
    Collaborators
    Urotronic Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    A post-marketing study using Optilume Catheter System for benign prostatic hyperplasia.
    Detailed Description
    This is a post-marketing study for using Optilume Catheter System, which is a Dilation Drug Coated Balloon (DCB) Catheter, to treat benign prostatic hyperplasia. Participants will go through screening process which include uroflow test (measure the strength of urine flow), post-void residual volume by bladder scan, questionnaires and transrectal ultrasound (TRUS) to determine the eligibility to the study. Participants will be followed up for 1 year after Optilume treatment procedure.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Benign Prostatic Hyperplasia
    Keywords
    Optilume, MIST

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Optilume Catheter System, which is a Dilation Drug Coated Balloon (DCB) Catheter.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment
    Arm Type
    Experimental
    Arm Description
    Optilume Catheter System
    Intervention Type
    Device
    Intervention Name(s)
    Optilume Catheter System
    Intervention Description
    Optilume Catheter System, which is a Dilation Drug Coated Balloon (DCB) Catheter
    Primary Outcome Measure Information:
    Title
    Efficacy: Responder Rate at 12 months
    Description
    ≥30% improvement in International Prostate Symptom Score (IPSS) score without the need of an additional surgical or minimally invasive procedure. IPSS score ranges from 0-35 (higher score means worse symptoms)
    Time Frame
    12 months post treatment
    Title
    Safety (adverse events)
    Description
    Frequency and severity of treatment related adverse events will be reported using the Clavien-Dindo severity grading system.
    Time Frame
    Within 12 months post treatment
    Secondary Outcome Measure Information:
    Title
    Change in IPSS & IPSS QoL (questionnaire)
    Description
    IPSS & IPSS QoL questionnaire
    Time Frame
    12 months post treatment
    Title
    Change in Qmax (maximum flow rate)
    Description
    Uroflow to measure maximum flow rate
    Time Frame
    12 months post treatment
    Title
    Change in PVR (post-void residual)
    Description
    Bladder scanner to measure post-void residual
    Time Frame
    12 months post treatment
    Title
    Change in sexual function (International Index of Erectile Function, IIEF questionnaire)
    Description
    IIEF questionnaire. Lower score in IIEF means worse in erectile dysfunction.
    Time Frame
    12 months post treatment
    Title
    Change in sexual function (Male Sexual Health Questionnaire ejaculatory dysfunction, MSHQ-EjD questionnaire)
    Description
    MSHQ-EjD questionnaire. Lower score in MSHQ-EjD means worse in ejaculation function.
    Time Frame
    12 months post treatment
    Title
    Quality of Recovery (QoR) Visual Analogue Scale (VAS) score at 30 days.
    Description
    QoR VAS questionnaire. Higher score means good in recovery.
    Time Frame
    30 days post treatment
    Title
    Health care usage
    Description
    Procedure time
    Time Frame
    30 days post treatment
    Title
    Health care usage
    Description
    Readmission rate within 30days
    Time Frame
    30 days post treatment
    Title
    Rate of repeat surgical intervention
    Description
    Number of participants that need repeated surgical intervention
    Time Frame
    12 months post treatment

    10. Eligibility

    Sex
    Male
    Gender Based
    Yes
    Gender Eligibility Description
    Male
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male subject with symptomatic BPH NOTE: Symptomatic BPH is defined as an International Prostate Symptom Score (IPSS) ≥ 13 and peak urinary flow rate (Qmax) of ≤15 mL/sec Prostate dimensions suitable for treatment with the Optilume BPH Catheter System in accordance with the approved Instructions for Use NOTE: Prostate volume between 20 to 80 gm and prostatic urethral length between 32 mm and 55 mm as determined by TRUS 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 follow-up requirements Unwilling to abstain from sexual intercourse or use a condom for 30 days post-procedure and 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 Confirmed or suspected malignancy of prostate or bladder Active urinary tract infection (UTI) confirmed by culture History of overt urinary incontinence requiring use of pads NOTE: Pad usage for post-micturition dribble is acceptable Presence of confounding diagnoses impacting lower urinary tract symptoms or bladder function (e.g. urethral strictures, bladder neck contracture, neurogenic bladder, detrusor instability, bladder stones, etc.) History of chronic urinary retention (e.g. PVR ≥300mL on two separate occasions, or catheter dependent drainage) Anatomy (e.g. presence of false passage or size of meatus) is not suitable for treatment with the Optilume BPH Catheter System Significant obstruction from median lobe in the opinion of the investigator Disease or other health condition that is not suitable for this study
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Iris Chan
    Phone
    416-603-5800
    Ext
    5033
    Email
    iris.chan2@uhn.ca
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dean Elterman
    Email
    dean.elterman@uhn.ca

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Optilume BPH Catheter System in Benign Prostatic Hyperplasia (BPH)

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