Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Minimally Invasive Prostatic Vapor Ablation for the Treatment of BPH in Large Prostates (Rezūm XL) (Rezūm XL)

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: NCT03605745
Recruitment Status : Terminated (Sponsor decided to terminate the study due to business reasons)
First Posted : July 30, 2018
Results First Posted : August 10, 2021
Last Update Posted : August 10, 2021
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Tracking Information
First Submitted Date  ICMJE July 23, 2018
First Posted Date  ICMJE July 30, 2018
Results First Submitted Date  ICMJE June 4, 2021
Results First Posted Date  ICMJE August 10, 2021
Last Update Posted Date August 10, 2021
Actual Study Start Date  ICMJE June 19, 2018
Actual Primary Completion Date June 25, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2021)
  • Number of Participants With ≥ 30% Improvement in Symptoms as Measured by the International Prostate Symptom Score (IPSS) [ Time Frame: 6 Months ]
    The proportion of the intent-to-treat (ITT) analysis population that responds to the Rezum therapy is reported. A responder is defined as a subject who has an improvement in International Prostate Symptom Score (IPSS) > 30% from baseline to 6 months post-therapy. IPSS scores range from 0 (no symptoms) to 35 (severe symptoms). Improvement in symptoms is shown by a reduction in score.
  • Number of Participants With Post Procedure Device Related Serious Complications [ Time Frame: 6 Months ]
    Assess the composite rate of post procedure device related serious complications in treated subjects through 6 months follow-up.
Original Primary Outcome Measures  ICMJE
 (submitted: July 23, 2018)
  • IPSS Improvement [ Time Frame: 6 Months ]
    The proportion of the intent-to-treat (ITT) analysis population that responds to therapy must be statistically significantly greater than 50%. A responder is defined as a subject who has an IPSS improvement > 30% post-treatment compared to baseline.
  • Post Procedure Device Related Serious Complications [ Time Frame: 6 Months ]
    Demonstration that the composite rate of post procedure device related serious complications in treated subjects is statistically significantly less than 12% at 6 months.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2021)
  • Number of Subjects With Device-related Retention Catheterizations [ Time Frame: 6 Month ]
    This safety endpoint will be to characterize the rate of post procedure device-related serious retention catheterizations at 6 months.
  • Change in Lower Urinary Tract Symptoms as Assessed by the Absolute Change in IPSS Score From Baseline to Follow-up [ Time Frame: Baseline, 6 weeks, 3 months, 6 months, 1 year ]
    The change in IPSS from baseline to each follow-up visit was determined. IPSS scores range from 0 (no symptoms) to 35 (severe symptoms). Improvement in symptoms is shown by a reduction in score.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 23, 2018)
  • Device-related retention catheterization rate [ Time Frame: 6 Month ]
  • Absolute IPSS improvement at 6 Months [ Time Frame: 6 Months ]
  • Percent IPSS Responders at 1 year [ Time Frame: 1 Year ]
  • Percent IPSS Responders at 2 years [ Time Frame: 2 Years ]
  • Percent IPSS Responders at 3 years [ Time Frame: 3 Years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Minimally Invasive Prostatic Vapor Ablation for the Treatment of BPH in Large Prostates (Rezūm XL)
Official Title  ICMJE Minimally Invasive Prostatic Vapor Ablation - Multicenter, Single Arm Study for the Treatment of BPH in Large Prostates (Rezūm XL)
Brief Summary Prospective, multicenter, single arm clinical trial designed to evaluate the safety of the Rezūm System in treating subjects with symptomatic BPH for prostate sizes >80cm3 and ≤150 cm3.
Detailed Description A prospective, multicenter, single arm clinical trial designed to evaluate the safety of the Rezūm System in treating subjects with symptomatic BPH for prostate sizes >80cm3 and ≤150 cm3.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
This study is a prospective, non-randomized clinical trial of subjects with benign prostatic hypertrophy (BPH).
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • BPH With Urinary Obstruction
  • BPH
  • BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms
Intervention  ICMJE Device: Prostatic Vapor Ablation

Rezūm uses the stored thermal energy in water vapor (steam) to treat the extra prostate tissue that is causing symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate.

Inside a hand-held device, radiofrequency energy is applied to a few drops of water to create vapor (steam). The water vapor is injected into the prostate tissue that is blocking the flow of urine from the bladder, where it immediately turns back to water, releasing the energy stored in the vapor into the cell membranes. At this point, the cells are gently and immediately damaged, causing cell death. Over time, the body absorbs the treated tissue through its natural healing response.

Other Names:
  • Rezum
  • Water Vapor Ablation
Study Arms  ICMJE Experimental: Treatment
Prostatic Vapor Ablation with Rezum
Intervention: Device: Prostatic Vapor Ablation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 17, 2020)
47
Original Estimated Enrollment  ICMJE
 (submitted: July 23, 2018)
88
Actual Study Completion Date  ICMJE August 11, 2020
Actual Primary Completion Date June 25, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male subjects ≥ 50 years of age who have symptomatic BPH.
  2. International Prostate Symptom Score (IPSS) score ≥ 13.
  3. Peak urinary flow rate (Qmax): ≥ 5ml/sec to ≤ 12 ml/sec with minimum voided volume of ≥ 125 ml.
  4. Post-void residual (PVR) ≤300 ml.
  5. Prostate volume >80 cm3 to ≤150 cm3

Exclusion Criteria:

Urology:

  1. Any prior invasive prostate intervention (e.g., "Radiofrequency" thermotherapy, balloon, microwave thermotherapy, "Prostatic Urethral Lift", "Transurethral Resection", or laser) or other surgical interventions of the prostate.
  2. Undergone a prostate biopsy within 60 days prior to the scheduled treatment date or has an imminent need for surgery.
  3. Verified acute bacterial prostatitis within last 12 months documented by culture.
  4. Active or history of epididymitis within the past 3 months.
  5. Urethral strictures, bladder neck contracture, unusual anatomy or muscle spasms that would prevent the introduction and use of the Rezūm device.
  6. Diagnosed bladder, urethral or ureteral stones or active stone passage in the past 6 months, provided that stones that are known to be in the kidney and have been stable for a period exceeding 3 months are permissible.
  7. Subject interested in maintaining fertility.
  8. Use of the following medications where the dose is not stable (stable dose defined as the same medication and dose in the last three months):

    1. Beta-blockers;
    2. Anticonvulsants;
    3. Antispasmodics;
    4. Antihistamines;
    5. Alpha blockers for BPH and anticholinergics or cholinergics;
    6. Type II, 5-alpha reductase inhibitor (e.g., finasteride (Proscar, Propecia));
    7. Dual 5-alpha reductase inhibitor (e.g., dutasteride (Avodart));
    8. Estrogen, drug-producing androgen suppression, or anabolic steroids;
    9. PD5 Inhibitors (e.g., Viagra, Levitra or Cialis)
  9. Subjects who have had an incidence of spontaneous urinary retention either treated with indwelling transurethral catheter or suprapubic catheter 6 months prior to baseline. A provoked episode now resolved is still admissible
  10. Evidence of atonic neurogenic bladder evaluated by a baseline urodynamic assessment.
  11. Visible hematuria with subject urine sample without a known contributing factor.
  12. Presence of a penile implant or stent(s) in the urethra or prostate
  13. Active urinary tract infection by culture within 7 days of treatment or two documented independent urinary tract infections of any type in the past 6 months.

    Gastroenterology:

  14. Previous pelvic irradiation or radical pelvic surgery.
  15. Previous rectal surgery (other than hemorrhoidectomy) or known history of rectal disease.

    Nephrology:

  16. Compromised renal function defined as serum creatinine > 2.0 mg/dl.
  17. Hydronephrosis (Grade 2 or higher).

    Oncology:

  18. Prostate cancer testing:

    If PSA is > 2.5 ng/ml and ≤ 10 ng/ml with free PSA <25%, prostate cancer for the subject must be/had been ruled out through a negative biopsy prior to enrollment

    • Males 50-59 years - PSA is >2.5 ng/ml and ≤10 ng/ml with free PSA <25%,
    • Males 60+ years - PSA is >4 ng/ml and ≤10 ng/ml, with free PSA <25%
  19. History of confirmed malignancy or cancer of the prostate or bladder; however, high grade prostatic intraepithelial "PIN" is acceptable.
  20. History of cancer in non-genitourinary system that 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 of enrollment.

    Cardiology:

  21. History of clinically significant congestive heart failure (i.e., NYHA Class III and IV).
  22. Cardiac arrhythmias that are not controlled by medication and/or medical device.
  23. An episode of unstable angina pectoris, a myocardial infarction, transient ischemic attack, or a cerebrovascular accident within the past six months.

    Pulmonology:

  24. History of significant respiratory disease where hospitalization for the disease is required.

    Hematology:

  25. Diagnosed or suspected bleeding disorder, or coagulopathies.
  26. Use of antiplatelet or anticoagulant medication except low dose aspirin (<100mg/day) within 10 days prior to treatment.

    Endocrinology:

  27. History of diabetes not controlled by a stable dose of medication over the past three months, provided that patients with a hemoglobin A1c <8.0% are allowed.

    Immunology:

  28. History of immunosuppressive conditions (e.g., AIDS, post-transplant).

    Neurology:

  29. Any cognitive or psychiatric condition that interferes with or precludes direct and accurate communication with the study investigator regarding the study or affect the ability to complete the study quality of life questionnaires.
  30. Diagnosed or suspected primary neurologic conditions such as multiple sclerosis or Parkinson's disease or other neurological diseases known to affect bladder function, sphincter function or poor detrusor muscle function (< 25% of accepted and established nomograms).

    General:

  31. Currently enrolled in any other pre-approval investigational study in the US (does not apply to long-term post-market studies unless these studies might clinically interfere with the current study endpoints (e.g., limit use of study-required medication, etc.).
  32. Any significant medical history that would pose an unreasonable risk or make the subject unsuitable for the study.
  33. Inability to provide a legally effective "Informed Consent Form" and/or comply with all the required follow-up requirements.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03605745
Other Study ID Numbers  ICMJE 3034-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Boston Scientific Corporation
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Boston Scientific Corporation
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Henry Woo, MD Sydney Adventist Hospital
PRS Account Boston Scientific Corporation
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP