The Zenflow Spring System Feasibility and Safety Study

NCT02786290 | Unknown

• 1 other identifier: CLIN-0002
• Study Type: interventional
• Target: 30
• Locations: 2 countries
• Sites: 3

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).

Conditions

Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  Intraoperative

• Occurrence of device and/or procedure related Adverse Events as determined by investigator and independent medical reviewer

  Frequency and severity of any device or procedure related adverse events, by subject.

  Intraoperative

• Occurrence of Adverse Event specific to indwelling catheterization, descriptive analysis

  Frequency of indwelling catheterization = or \> 7 days following placement of the investigational device.

  Seven days following implantation of the investigational device

• Effectiveness of implant measured through symptom improvement (International Prostate Symptom Score - IPSS)

  Subjects should demonstrate improvement of \> or = to 3 point reduction from baseline measurement.

  3 months following device placement

Secondary Outcomes (6)

• Assessment of Sexual Health using the Sexual Health in Men (SHIM) questionnaire

  6 months, 12-,24-,36-, months post implantation

• Assessment of Incontinence, using the Incontinence Severity Index (ISI) questionnaire

  2 weeks, 1 month, 3 months

• Observation of pain using a validated Visual Analogue Scale (VAS) questionnaire

  through 3 month follow-up

• Improvement in Uroflowmetry compared to baseline

  3-, 6-, 12-, 24-, 36-months post implantation

• Effectiveness of implant measured through symptom improvement (International Prostate Symptom Score - IPSS)

  12 months 24 months and 36 months

Study Arms (1)

Treatment Group

EXPERIMENTAL

Receives intervention with the Zenflow Spring System.

Device: Zenflow Spring System

Interventions

Zenflow Spring System DEVICE

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.

Treatment Group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 80 years of age
• Baseline IPSS score \> 13, and a baseline Quality of Life (Qol) question score \> 3
• Prostate volume 25 - 80 cc by Trans Rectal Ultrasound (TRUS), measured within past 90 days
• 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.
• Failed or intolerant to medication regimen for the treatment of LUTS.

You may not qualify if:

• Participants will be excluded from participating in this trial if they meet any of the following criteria:
• Obstructive median prostatic lobe or high bladder neck
• Urethral stricture, meatal stenosis, or bladder neck obstruction - either current, or recurrent requiring 2 or more dilatations
• 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
• 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)
• 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)
• History of chronic urinary retention. (New Zealand Only, up to 5 patients)
• History of neurogenic bladder
• Compromised renal function (e.g., serum creatinine \> 1.8 mg/dl)
• Concomitant Urinary Tract Infection (UTI)
• Concomitant bladder stones
• Confirmed or suspected prostate/bladder cancer
• Previous pelvic irradiation or radical pelvic surgery
• Previous prostate surgery, stent implantations, laser prostatectomy, hyperthermia or another invasive treatment to the prostate
• Chronic prostatitis, or recurring prostatitis within the past 12 months

Sponsors & Collaborators

• Zenflow, Inc.: lead

Study Sites (3)

MBAL "Tokuda Bolnitsa Sofia" AD

Sofia, 1407, Bulgaria

Location

RoundHay Medical Center

Nelson South, Nelson Region, 7010, New Zealand

Location

Tauranga Urology Research Ltd

Tauranga, 3140, New Zealand

Location

Related Publications (20)

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MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Peter Gilling, MD

  Tauranga Urology Research Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2016
• First Posted: May 30, 2016
• Study Start: April 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: January 1, 2020
• Last Updated: February 6, 2019

Record last verified: 2019-02

Locations

NZ (2); BU (1)