The Zenflow Spring System EU Safety and Performance Study

NCT03577236 | Unknown DMC

• 1 other identifier: CLIN-0050
• Study Type: interventional
• Target: 50
• Locations: 2 countries
• Sites: 5

Brief Summary

The objectives of the trial are to demonstrate the safety and performance of the Zenflow Spring System in relieving the symptoms of obstructive Benign Prostatic Hyperplasia (BPH).

Conditions

Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (3)

• Need for urinary catheterization

  Rate of extended post-operative urinary catheterization

  7 days after the procedure

• Successful placement of the Zenflow Spring Implant

  Successful deployment and procedural success for the Zenflow System to implant the Spring device in the operating room or an out-patient clinical setting.

  Day of discharge up to 7 days following device placement

• Effectiveness of the Spring Implant in reducing symptoms of Benign Prostatic Hyperplasia (BPH) using the International Prostate Symptom Score and Quality of Life Score (IPSS+QoL)

  The patient is asked to respond to 7 questions related to his urinary health using a rating scale of 0 to 5 where zero is excellent and 5 is the worst possible. The responses to the 7 questions are tallied for a total score. In addition the patient is asked 1 question related to his Quality of Life. The possible responses range from 0 to 6 where 0 is the best and 6 is the worst.

  Baseline and 3 months

Secondary Outcomes (8)

• Incidence of procedure or device related serious adverse events

  Up to 30 days

• Assessment of Sexual Health Assessment: Change in sexual health measured by change in the Sexual Health Inventory for Men (SHIM) questionnaire score

  Baseline, 3, 6, 12, & 24 months

• Assessment of Sexual Health Assessment: Change in sexual health measured by change in ability to ejaculate using the Male Sexual Health Questionnaire - Ejaculatory domain (MSHQ-EjD)

  Baseline, 3, 6, 12, & 24 months

• Assessment of Pain, evaluated using a Visual Analog Score (VAS) of 1 to 10

  Baseline, 2 weeks, 1 month and 3 months

• Assessment of Adverse Events

  Up to 2 years

Study Arms (1)

Zenflow Spring System

EXPERIMENTAL

Receives treatment with the investigational device

Device: Zenflow Spring System

Interventions

Zenflow Spring System DEVICE

The Zenflow Spring System consists of the Spring Delivery System with Implant, Spring Scope, Camera Control Unit (CCU), Measurement Tool, and Spring Retrieval Tool.

Also known as: Spring Implant

Zenflow Spring System

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is able and willing to comply with all the assessments of the study
• Patient or patient's legal representative has been informed of the nature of the study, agrees to participate and has signed the informed consent form
• ≥ 45 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) or abdominal ultrasound, measured within past 90 days and prostatic urethral length between 2.5- 4.5 cm
• Failed, intolerant, or patient choice to not take a medication regimen for the treatment of LUTS
• Patient must meet ONE of the following criteria:
• Baseline PSA \<= 2.5ng/mL
• Baseline PSA \>2.5 ng/mL and \<=10 ng/mL AND free PSA \>=25% of total PSA (no biopsy required or negative biopsy)
• Baseline PSA \>10ng/mL AND negative prostate biopsy1 result within 12 months
• Negative prostate biopsy1 within 12 months if abnormal digital rectal examination
• Tesla MRI of the prostate, with normal findings, within 12 months prior to the baseline visit

You may not qualify if:

• Obstructive intravesical median prostatic lobe which, in the opinion of the Investigator, would not benefit from treatment
• Urethral stricture, meatal stenosis, or bladder neck obstruction - either current, or recurrent requiring 2 or more dilations as reported in the patient's history
• Requiring self-catheterization to void
• Baseline PSA \> 10 ng/mL or confirmed or suspected prostate cancer
• Any of the following, taken from a single uroflowmetry reading:
• Peak urinary flow rate \> 12 ml/second
• Post-void residual (PVR) \> 250 ml
• Peak Urinary flow rate of \> 15 ml/second
• \< 125ml urinary volume voided at baseline (pre-bladder urinary volume of ≥ 150 ml required)
• Other condition or disease that might cause urinary retention
• History of other diseases causing voiding dysfunction
• Concomitant Urinary Tract Infection (UTI) (subject can be enrolled following successful treatment of UTI and a clean urine test), or a history of recurrent or chronic UTIs (defined as 2 or more UTIs in the past 12 months)
• Concomitant bladder stones
• Previous pelvic irradiation or radical pelvic surgery
• Previous prostate surgery, stent implantations, laser prostatectomy, hyperthermia or another invasive treatment to the prostate

Sponsors & Collaborators

• Zenflow, Inc.: lead

Study Sites (5)

Australian Clinical Trials

Wahroonga, New South Wales, 2076, Australia

NOT YET RECRUITING

South Coast Urology

Wollongong, New South Wales, 2500, Australia

RECRUITING

Goldfields Urology

Bendigo, Victoria, 3550, Australia

RECRUITING

Royal Melbourne Hospital

Melbourne, Victoria, 3050, Australia

RECRUITING

Urology Bay of Plenty

Tauranga, 3140, New Zealand

RECRUITING

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

Central Study Contacts

Debra Cogan, B.A., RN

CONTACT

+001 408 515-0820; dcogan@zenflow.com

Nicholas Damiano, MS

CONTACT

+001 650 642-9658; Nick@zenflow.com

Study Design

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

Model Details: Multi-center, prospective, single-arm.

Study Record Dates

• First Submitted: May 16, 2018
• First Posted: July 5, 2018
• Study Start: January 16, 2019
• Primary Completion: December 1, 2022
• Study Completion: May 30, 2024
• Last Updated: July 22, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1); AU (4)