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History of Changes for Study: NCT03605745
Minimally Invasive Prostatic Vapor Ablation for the Treatment of BPH in Large Prostates (Rezūm XL) (Rezūm XL)
Latest version (submitted July 19, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 July 23, 2018 None (earliest Version on record)
2 October 22, 2018 Contacts/Locations and Study Status
3 March 11, 2019 Contacts/Locations and Study Status
4 August 5, 2019 Study Status, Contacts/Locations and Study Identification
5 September 19, 2019 Recruitment Status, Contacts/Locations, Study Status, Eligibility and Outcome Measures
6 November 4, 2019 Study Status
7 January 14, 2020 Study Status
8 May 7, 2020 Study Status, IPDSharing and Outcome Measures
9 August 17, 2020 Recruitment Status, Study Status and Study Design
10 August 31, 2020 Study Status and Study Description
11 June 4, 2021
Quality Control Review has not concluded Returned: June 25, 2021
Outcome Measures, Study Status, Document Section
12 July 19, 2021 Outcome Measures, Study Status
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Study NCT03605745
Submitted Date:  July 23, 2018 (v1)

Open or close this module Study Identification
Unique Protocol ID: 3034-001
Brief Title: Minimally Invasive Prostatic Vapor Ablation for the Treatment of BPH in Large Prostates (Rezūm XL) (Rezūm XL)
Official Title: Minimally Invasive Prostatic Vapor Ablation - Multicenter, Single Arm Study for the Treatment of BPH in Large Prostates (Rezūm XL)
Secondary IDs:
Open or close this module Study Status
Record Verification: July 2018
Overall Status: Recruiting
Study Start: May 30, 2018
Primary Completion: December 30, 2018 [Anticipated]
Study Completion: June 30, 2022 [Anticipated]
First Submitted: July 23, 2018
First Submitted that
Met QC Criteria:
July 23, 2018
First Posted: July 30, 2018 [Actual]
Last Update Submitted that
Met QC Criteria:
July 23, 2018
Last Update Posted: July 30, 2018 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Boston Scientific Corporation
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: Yes
Unapproved/Uncleared Device:
Pediatric Postmarket Surveillance:
Data Monitoring: No
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: BPH With Urinary Obstruction
BPH
BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms
Keywords: BPH
Minimally Invasive
Water Vapor Therapy
Rezum
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Single Group Assignment
This study is a prospective, non-randomized clinical trial of subjects with benign prostatic hypertrophy (BPH).
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 88 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Treatment
Prostatic Vapor Ablation with Rezum
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
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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.
2. 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.
Secondary Outcome Measures:
1. Device-related retention catheterization rate
[ Time Frame: 6 Month ]

2. Absolute IPSS improvement at 6 Months
[ Time Frame: 6 Months ]

3. Percent IPSS Responders at 1 year
[ Time Frame: 1 Year ]

4. Percent IPSS Responders at 2 years
[ Time Frame: 2 Years ]

5. Percent IPSS Responders at 3 years
[ Time Frame: 3 Years ]

Open or close this module Eligibility
Minimum Age: 50 Years
Maximum Age:
Sex: Male
Gender Based: Yes
Accepts Healthy Volunteers: No
Criteria:

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.
Open or close this module Contacts/Locations
Central Contact Person: Andrea Stone
Telephone: 612-434-5913
Email: andrea.stone@bsci.com
Central Contact Backup: Gwen LeTourneau
Telephone: 612-503-7916
Email: gwen.letourneau@bsci.com
Study Officials: Henry Woo, MD
Principal Investigator
Sydney Adventist Hospital
Locations: United States, Arizona
Arizona Urology Specialists
[Recruiting]
Scottsdale, Arizona, United States, 85258
Contact:Contact: Nicole Nunez 480-661-2662
Contact:Principal Investigator: Micheal F. Darson, MD
Contact:Sub-Investigator: Erik E. Alexander, MD
United States, Indiana
First Urology
[Recruiting]
Jeffersonville, Indiana, United States, 47130
Contact:Contact: Elizabeth Burks, CRC, MA 812-206-8162 eburks@lsturology.com
Contact:Principal Investigator: James L. Bailen, MD
Contact:Sub-Investigator: Charles Goodwin, MD
United States, Maryland
Chesapeake Urology Associates, LLC
[Recruiting]
Towson, Maryland, United States, 21204
Contact:Contact: Jacqueline Burmer 443-471-5750 jburmer@cua.md
Contact:Principal Investigator: Richard M. Levin, MD
Contact:Sub-Investigator: Jonathan Rubenstein, MD
United States, New Jersey
Jersey Urology
[Recruiting]
Somers Point, New Jersey, United States, 08244
Contact:Contact: Taylor Shotwell 609-703-0125 tshotwell@jerseyurology.com
Contact:Principal Investigator: Andrew L. Hirsh, MD
United States, Texas
Houston Metro
[Recruiting]
Houston, Texas, United States, 77030
Contact:Contact: Emily Fisher, PA-C 713-790-9779 Emily.fisher@hmutx.com
Contact:Principal Investigator: Ricardo R. Gonzalez, MD
Urology San Antonio
[Recruiting]
San Antonio, Texas, United States, 78229
Contact:Contact: Jennifer Cruz, RN 210-617-4116 jennifer.cruz@urolgysa.com
Contact:Principal Investigator: Christopher H. Cantrill, MD
Open or close this module IPDSharing
Plan to Share IPD: Undecided
Open or close this module References
Citations:
Links:
Available IPD/Information:

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