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Rezum FIM Optimization (Rezum FIM)

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ClinicalTrials.gov Identifier: NCT02940392
Recruitment Status : Active, not recruiting
First Posted : October 20, 2016
Last Update Posted : October 20, 2016
Sponsor:
Information provided by (Responsible Party):
NxThera Inc

Brief Summary:
Evaluate the effect of the NxThera BPH Rezum System on prostate tissue in subjects suffering from LUTS symptoms secondary to benign prostatic hyperplasia (BPH).

Condition or disease Intervention/treatment Phase
Benign Prostatic Hyperplasia Adenoma, Prostatic Prostatic Adenoma Prostatic Hyperplasia, Benign Prostatic Hypertrophy Prostatic Hypertrophy, Benign Rezum Device: Rezum System Not Applicable

Detailed Description:
Subjects with BPH symptoms were treated with the Rezum device with a range of thermal energies (as measured by calorie output) to optimize the setting for maximum lesion size with minimal intra and post-procedure discomfort. Lesion size and ablated tissue resorption rate was followed post-procedure at 1 week, 1 month, 3 months, and 6 months.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Rezum First in Man Feasibility Study for the Treatment of BPH With the Rezum System
Study Start Date : February 2012
Actual Primary Completion Date : December 2012
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Rezum Treatment
Patients will receive the Rezūm transurethral needle ablation procedure to treat benign prostatic hyperplasia.
Device: Rezum System

The Rezūm System is designed to treat patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death.

The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.

Other Names:
  • Rezum Procedure
  • Rezum
  • Water Vapor Ablation
  • Rezum Delivery Device
  • Rezum Generator




Primary Outcome Measures :
  1. Lesion Characteristics via MRI [ Time Frame: 1 week post procedure ]
    Lesion size and treated tissue resorption rate was measured by gadolinium enhanced MRI

  2. Change in IPSS [ Time Frame: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years ]
    Change in IPSS score from Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years


Secondary Outcome Measures :
  1. Intra-procedure Pain [ Time Frame: Procedure day ]
    Procedural pain was assessed using the Wong Baker scale. Subjects were asked to rate the level of pain and discomfort during the treatment.

  2. Post-Procedure Catheterization [ Time Frame: 24 hours post procedure ]
    Post procedure catheterization documented



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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male subjects > 45 years of age who have symptomatic / obstructive symptoms secondary to BPH requiring invasive intervention.
  2. IPSS score of ≥ 15.
  3. Qmax: Peak flow rate ≤ 15 ml/sec.
  4. Post-void residual (PVR) < 300 ml.
  5. Prostate transverse diameter > 30 mm.
  6. Prostate volume between 20 to 120 gm.
  7. Voided volume ≥ 125 ml.
  8. Subject able to complete the study protocol in the opinion of the Principal Investigator.
  9. Subject must be willing to undergo the procedure without anesthesia.

Exclusion Criteria:

  1. History of any illness or surgery that in the opinion of the Principal Investigator may confound the results of the study.
  2. Presence of a penile implant.
  3. Any prior minimally invasive intervention (e.g. TUNA,Laser, Microwave) or surgical intervention for the symptoms of BPH.
  4. Currently enrolled in another clinical trial.
  5. Confirmed or suspected malignancy of prostate or bladder.
  6. Previous rectal surgery (other than hemorrhoidectomy) or history of rectal disease.
  7. Previous pelvic irradiation or radical pelvic surgery.
  8. Documented active urinary tract infection 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).
  9. Neurogenic bladder or sphincter abnormalities.
  10. Urethral strictures, bladder neck contracture or muscle spasms.
  11. Bleeding disorder (note that use of anti-platelet medication is not an exclusion criterion).
  12. Subjects who are interested in maintaining fertility.
  13. Use of concomitant (or recent) medications to include the following:

    1. Beta blockers, antihistamines, anticonvulsants, and antispasmodics within 1 week of treatment, unless there is documented evidence of stable dosing for last 6 months (e.g., no dose changes).
    2. Alpha blockers, antidepressants, anticholinergics, androgens, or gonadotropin-releasing hormonal analogs within 2 weeks of treatment.
    3. 5-alpha reductase inhibitor within the last 6 months
  14. Subject is unable or unwilling to go through a "washout" period for the above medications prior to treatment.
  15. Subject has chronic urinary retention.
  16. Significant urge incontinence.
  17. Poor detrusor muscle function.
  18. Neurological disorders which might affect bladder or sphincter function.
  19. Bladder stones.
  20. Renal impairment.
  21. In the opinion of the Principal Investigator, subject will not be able to adequately tolerate a rigid cystoscopy-type procedure.
  22. Unable or unwilling to sign the Informed Consent Form (ICF) and/or comply with all the required follow-up requirements.
  23. Any cognitive disorder that interferes with or precludes a subject from directly and accurately communicating with the Principal Investigator regarding the study.
  24. Peripheral arterial disease with intermittent claudication or Leriches Syndrome (i.e., claudication of the buttocks or perineum).
  25. Biopsy of the prostate within 30 days prior to the Rezūm procedure.

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): NCT02940392


Locations
Dominican Republic
Clinica Canela
La Romana, Dominican Republic
Sponsors and Collaborators
NxThera Inc
Investigators
Study Director: Cindy B Ogden Vice President, Clinical Affairs - NxThera, Inc.

Responsible Party: NxThera Inc
ClinicalTrials.gov Identifier: NCT02940392     History of Changes
Other Study ID Numbers: 1633-001
First Posted: October 20, 2016    Key Record Dates
Last Update Posted: October 20, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by NxThera Inc:
Rezum

Additional relevant MeSH terms:
Hyperplasia
Adenoma
Prostatic Hyperplasia
Hypertrophy
Pathologic Processes
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Prostatic Diseases
Genital Diseases, Male
Pathological Conditions, Anatomical