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The Zenflow Spring System Feasibility and Safety Study (ZEST)

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: NCT02786290
Recruitment Status : Active, not recruiting
First Posted : May 30, 2016
Last Update Posted : February 6, 2019
Sponsor:
Information provided by (Responsible Party):
Zenflow, Inc.

Brief Summary:
This is a First in Human study to assess the feasibility, safety and effectiveness of the Zenflow Spring System in relieving the symptoms of obstructive Benign Prostatic Hyperplasia (BPH).

Condition or disease Intervention/treatment Phase
Benign Prostatic Hyperplasia Device: Zenflow Spring System Not Applicable

Detailed Description:
The purpose of the Zenflow Study is to evaluate the feasibility and safety of a novel prostatic urethral implant for the treatment of Lower Urinary Tract Symptoms (LUTS) that arise due to bladder outlet obstruction (BOO), secondary to the presence of Benign Prostatic Hypertrophy (BPH). Effectiveness will also be measured. It is intended that the features of the Zenflow Spring will provide an effective office-based treatment and management therapy for BPH with little or no side effects.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Zenflow Spring System Feasibility and Safety Study (ZEST)
Study Start Date : April 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment Group
Receives intervention with the Zenflow Spring System.
Device: Zenflow Spring System
The Zenflow Spring is a nitinol urethral implant for the treatment of Lower Urinary Tract Symptoms (LUTS) that arise due to bladder outlet obstruction (BOO), secondary to the presence of Benign Prostatic Hypertrophy (BPH). The device is intended to be a permanent implant however it may be removed if necessary.




Primary Outcome Measures :
  1. Device Success defined as both 1) deliverability of the implant and 2) freedom from unanticipated adverse events (UAEs) not listed in the protocol or AEs that meet the protocol definition of Serious AEs. [ Time Frame: Intraoperative ]
    Frequency of Device Success is assessed by subject, for both successful device placement in the target anatomy and absence of serious or unanticipated adverse events through discharge.

  2. Occurrence of device and/or procedure related Adverse Events as determined by investigator and independent medical reviewer [ Time Frame: Intraoperative ]
    Frequency and severity of any device or procedure related adverse events, by subject.

  3. Occurrence of Adverse Event specific to indwelling catheterization, descriptive analysis [ Time Frame: Seven days following implantation of the investigational device ]
    Frequency of indwelling catheterization = or > 7 days following placement of the investigational device.

  4. Effectiveness of implant measured through symptom improvement (International Prostate Symptom Score - IPSS) [ Time Frame: 3 months following device placement ]
    Subjects should demonstrate improvement of > or = to 3 point reduction from baseline measurement.


Secondary Outcome Measures :
  1. Assessment of Sexual Health using the Sexual Health in Men (SHIM) questionnaire [ Time Frame: 6 months, 12-,24-,36-, months post implantation ]
    Observational assessment of subject scores on SHIM at the 6 months and 12 months visit, compared to baseline.

  2. Assessment of Incontinence, using the Incontinence Severity Index (ISI) questionnaire [ Time Frame: 2 weeks, 1 month, 3 months ]
    Observational assessment of subject scores on ISI at 2 weeks, 1 month and 3 months compared to baseline.

  3. Observation of pain using a validated Visual Analogue Scale (VAS) questionnaire [ Time Frame: through 3 month follow-up ]
    Observational assessment of subject reports of pain on the VAS questionnaire, at discharge and follow up visits up to 3 months, compared to baseline.

  4. Improvement in Uroflowmetry compared to baseline [ Time Frame: 3-, 6-, 12-, 24-, 36-months post implantation ]
    Uroflowmetry is measured at 3 months post implantation and compared to baseline

  5. Effectiveness of implant measured through symptom improvement (International Prostate Symptom Score - IPSS) [ Time Frame: 12 months 24 months and 36 months ]
    Observation of IPSS scores compared to baseline at 12 months follow up.

  6. Effectiveness of the treatment by assessing need for further treatment to alleviate symptoms of BPH. [ Time Frame: 12 months 24 months and 36 months ]
    Observation of incidence of repeat invasive treatment for LUTS through 12 months post-procedure



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 50 to 80 years of age
  2. Baseline IPSS score > 13, and a baseline Quality of Life (Qol) question score > 3
  3. Prostate volume 25 - 80 cc by Trans Rectal Ultrasound (TRUS), measured within past 90 days
  4. Anterior prostatic urethral length 2.5 - 4.0 cm by cystoscopy, as measured from bladder neck to verumontanum. TRUS will be accepted as a primary screening measure.
  5. Failed or intolerant to medication regimen for the treatment of LUTS.

Exclusion Criteria:

New Zealand only: A maximum of 5 participants in acute or chronic urinary retention may be included in the study provided they meet other entry criteria. Exclusion exemptions for these patients are described in 4a, 5a and they are exempt from #6.

Participants will be excluded from participating in this trial if they meet any of the following criteria:

  1. Obstructive median prostatic lobe or high bladder neck
  2. Urethral stricture, meatal stenosis, or bladder neck obstruction - either current, or recurrent requiring 2 or more dilatations
  3. Elevated Prostate Specific Antigen (PSA) (age 50-70 PSA ≥4; age 70+ PSA ≥6.5) unless negative biopsy within last 3 months, or a positive biopsy
  4. Post-void residual volume (PVR) > 250 ml, if not in acute retention 4a. No maximum post void residual volume required if patient in acute or chronic urinary retention. (New Zealand Only, up to 5 patients)
  5. Peak urinary flow rate > 12 ml/second, with ≥ 125 ml voided volume at baseline. 5a. No maximum urinary flow or minimum voided volume required if participant in acute or chronic urinary retention. (New Zealand Only, up to 5 patients)
  6. History of chronic urinary retention. (New Zealand Only, up to 5 patients)
  7. History of neurogenic bladder
  8. Compromised renal function (e.g., serum creatinine > 1.8 mg/dl)
  9. Concomitant Urinary Tract Infection (UTI)
  10. Concomitant bladder stones
  11. Confirmed or suspected prostate/bladder cancer
  12. Previous pelvic irradiation or radical pelvic surgery
  13. Previous prostate surgery, stent implantations, laser prostatectomy, hyperthermia or another invasive treatment to the prostate
  14. Chronic prostatitis, or recurring prostatitis within the past 12 months
  15. Serious concurrent medical conditions such as uncontrolled diabetes
  16. Known allergy to nickel
  17. Life expectancy less than 12 months
  18. Use of concomitant medications (e.g., anticholinergics, antispasmodics or antidepressants) affecting bladder function
  19. Anti-coagulant, anti-platelet, or thrombolytic medication other than Acetylsalicylic Acid (ASA) or Clopidogrel. ASA and Clopidogrel must be ceased 7 days prior to the procedure.
  20. 5--reductase inhibitors within 6 months of pre-treatment evaluation unless evidence of same drug dose for at least 6 months with a stable voiding pattern (the drug dose should not be altered or discontinued for entrance into or throughout the study).
  21. -blockers within 2 weeks of pre-treatment evaluation unless evidence of same drug dose for at least 6 months with a stable voiding pattern (the drug dose should not be altered or discontinued for entrance into or throughout the study).
  22. Future fertility concerns
  23. Any severe illness that might prevent study completion or would confound study results

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): NCT02786290


Locations
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Bulgaria
MBAL "Tokuda Bolnitsa Sofia" AD
Sofia, Bulgaria, 1407
New Zealand
RoundHay Medical Center
Nelson South, Nelson, New Zealand, 7010
Tauranga Urology Research Ltd
Tauranga, New Zealand, 3140
Sponsors and Collaborators
Zenflow, Inc.
Investigators
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Principal Investigator: Peter Gilling, MD Tauranga Urology Research Ltd.
Publications:

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Responsible Party: Zenflow, Inc.
ClinicalTrials.gov Identifier: NCT02786290    
Other Study ID Numbers: CLIN-0002
First Posted: May 30, 2016    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Hyperplasia
Pathologic Processes
Prostatic Diseases