The Zenflow Spring System EU Safety and Performance Study (ZEST EU)
Primary Purpose
Benign Prostatic Hyperplasia
Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Zenflow Spring System
Sponsored by
About this trial
This is an interventional treatment trial for Benign Prostatic Hyperplasia
Eligibility Criteria
Inclusion Criteria:
- 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
- 3 Tesla MRI of the prostate, with normal findings, within 12 months prior to the baseline visit
Exclusion Criteria:
- 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
- Chronic prostatitis, or recurring prostatitis within the past 12 months
- Known allergy to nickel
- Life expectancy less than 24 months
- Use of concomitant medications (e.g., anticholinergics, antispasmodics or antidepressants) affecting bladder function
- Inability to stop taking anticoagulants and/or antiplatelets for at least 3 days prior to the procedure or coumadin for at least 5 days prior to the procedure (low dose aspirin therapy not prohibited)
- Taking 5-alpha reductase inhibitors within 3 months of pre-treatment (baseline) 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 throughout the study)
Taking one of the following within 2 weeks of pre-treatment (baseline) evaluation:
- alpha-blockers,
- androgens,
- anticholinergics, or
- cholinergic medication gonadotropin releasing hormonal analogs
Taking one of the following within 24 hours of pre-treatment (baseline) evaluation:
- phenylephrine, or
- pseudoephedrine
- Future fertility concerns
- Any severe illness that might prevent study completion or would confound study results
Sites / Locations
- Australian Clinical Trials
- South Coast UrologyRecruiting
- Goldfields UrologyRecruiting
- Royal Melbourne HospitalRecruiting
- Urology Bay of PlentyRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Zenflow Spring System
Arm Description
Receives treatment with the investigational device
Outcomes
Primary Outcome Measures
Need for urinary catheterization
Rate of extended post-operative urinary catheterization
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.
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.
Secondary Outcome Measures
Incidence of procedure or device related serious adverse events
Assessment of any device or procedure related Serious Adverse Events (SAE)
Assessment of Sexual Health Assessment: Change in sexual health measured by change in the Sexual Health Inventory for Men (SHIM) questionnaire score
The patient selects the most appropriate response to 5 questions about his sexual health. Each response has an assigned value between 1 and 5. The numeric values are tallied for a total score.
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)
The patient selects the most appropriate response to 4 questions about his sexual health specific to ejaculation. Each response has an assigned value between 0 and 5.
Assessment of Pain, evaluated using a Visual Analog Score (VAS) of 1 to 10
Patient describes pain on a Visual Analog Scale (VAS). The scale is a line labeled 1 at the far left indicating minimal pain and 10 on the right, which is maximum pain.
Assessment of Adverse Events
Rate of adverse events related to the procedure or device.
Effectiveness of the Spring Implant in reducing symptoms of Benign Prostatic Hyperplasia (BPH)
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.
Effectiveness of the Spring Implant in reducing symptoms of Benign Prostatic Hyperplasia (BPH)
Improvement in flow of urine as measured by uroflowmetry machine.
Effectiveness of the Spring Implant in reducing symptoms of Benign Prostatic Hyperplasia (BPH)
Incidence of repeat invasive treatment for Lower Urinary Tract Symptoms (LUTS) or increase in dosage or initiation of new medication to treat symptoms of BPH.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03577236
Brief Title
The Zenflow Spring System EU Safety and Performance Study
Acronym
ZEST EU
Official Title
The Zenflow Spring System EU Safety and Performance Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 16, 2019 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
May 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zenflow, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
Detailed Description
A multi-center, prospective, single arm safety and performance trial. Subjects will be treated either in the Investigator's out-patient treatment room or in the OR, with local anaesthesia only. All subjects will be followed for the entire duration of the study until exit after the 60 month follow-up visit.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Multi-center, prospective, single-arm.
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Zenflow Spring System
Arm Type
Experimental
Arm Description
Receives treatment with the investigational device
Intervention Type
Device
Intervention Name(s)
Zenflow Spring System
Other Intervention Name(s)
Spring Implant
Intervention Description
The Zenflow Spring System consists of the Spring Delivery System with Implant, Spring Scope, Camera Control Unit (CCU), Measurement Tool, and Spring Retrieval Tool.
Primary Outcome Measure Information:
Title
Need for urinary catheterization
Description
Rate of extended post-operative urinary catheterization
Time Frame
7 days after the procedure
Title
Successful placement of the Zenflow Spring Implant
Description
Successful deployment and procedural success for the Zenflow System to implant the Spring device in the operating room or an out-patient clinical setting.
Time Frame
Day of discharge up to 7 days following device placement
Title
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)
Description
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.
Time Frame
Baseline and 3 months
Secondary Outcome Measure Information:
Title
Incidence of procedure or device related serious adverse events
Description
Assessment of any device or procedure related Serious Adverse Events (SAE)
Time Frame
Up to 30 days
Title
Assessment of Sexual Health Assessment: Change in sexual health measured by change in the Sexual Health Inventory for Men (SHIM) questionnaire score
Description
The patient selects the most appropriate response to 5 questions about his sexual health. Each response has an assigned value between 1 and 5. The numeric values are tallied for a total score.
Time Frame
Baseline, 3, 6, 12, & 24 months
Title
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)
Description
The patient selects the most appropriate response to 4 questions about his sexual health specific to ejaculation. Each response has an assigned value between 0 and 5.
Time Frame
Baseline, 3, 6, 12, & 24 months
Title
Assessment of Pain, evaluated using a Visual Analog Score (VAS) of 1 to 10
Description
Patient describes pain on a Visual Analog Scale (VAS). The scale is a line labeled 1 at the far left indicating minimal pain and 10 on the right, which is maximum pain.
Time Frame
Baseline, 2 weeks, 1 month and 3 months
Title
Assessment of Adverse Events
Description
Rate of adverse events related to the procedure or device.
Time Frame
Up to 2 years
Title
Effectiveness of the Spring Implant in reducing symptoms of Benign Prostatic Hyperplasia (BPH)
Description
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.
Time Frame
Baseline, 2 weeks, 1, 6, 12, 24 months
Title
Effectiveness of the Spring Implant in reducing symptoms of Benign Prostatic Hyperplasia (BPH)
Description
Improvement in flow of urine as measured by uroflowmetry machine.
Time Frame
Baseline, 2 weeks, 1, 3, 6, 12, 24 months
Title
Effectiveness of the Spring Implant in reducing symptoms of Benign Prostatic Hyperplasia (BPH)
Description
Incidence of repeat invasive treatment for Lower Urinary Tract Symptoms (LUTS) or increase in dosage or initiation of new medication to treat symptoms of BPH.
Time Frame
Up to 2 years
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
3 Tesla MRI of the prostate, with normal findings, within 12 months prior to the baseline visit
Exclusion Criteria:
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
Chronic prostatitis, or recurring prostatitis within the past 12 months
Known allergy to nickel
Life expectancy less than 24 months
Use of concomitant medications (e.g., anticholinergics, antispasmodics or antidepressants) affecting bladder function
Inability to stop taking anticoagulants and/or antiplatelets for at least 3 days prior to the procedure or coumadin for at least 5 days prior to the procedure (low dose aspirin therapy not prohibited)
Taking 5-alpha reductase inhibitors within 3 months of pre-treatment (baseline) 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 throughout the study)
Taking one of the following within 2 weeks of pre-treatment (baseline) evaluation:
alpha-blockers,
androgens,
anticholinergics, or
cholinergic medication gonadotropin releasing hormonal analogs
Taking one of the following within 24 hours of pre-treatment (baseline) evaluation:
phenylephrine, or
pseudoephedrine
Future fertility concerns
Any severe illness that might prevent study completion or would confound study results
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Debra Cogan, B.A., RN
Phone
+001 408 515-0820
Email
dcogan@zenflow.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nicholas Damiano, MS
Phone
+001 650 642-9658
Email
Nick@zenflow.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Gilling, MD
Organizational Affiliation
Tauranga Urology Research Ltd.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Australian Clinical Trials
City
Wahroonga
State/Province
New South Wales
ZIP/Postal Code
2076
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Penny Ombler
Phone
+61 2 9473 8765
Email
research@urologist.net.au
First Name & Middle Initial & Last Name & Degree
Henry Woo, MD
Facility Name
South Coast Urology
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie Edwards
Phone
+61 612 4271 6644
Email
nurse@southcoasturology.com.au
First Name & Middle Initial & Last Name & Degree
Peter Chin, MD
Facility Name
Goldfields Urology
City
Bendigo
State/Province
Victoria
ZIP/Postal Code
3550
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janelle Brennan, Miss, MD
Phone
+61354413130
First Name & Middle Initial & Last Name & Degree
Janet Bennett, CRA
Phone
+61354413130
Email
janet_bennett@goldfieldsurology.com.au
Facility Name
Royal Melbourne Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Verrelli
Phone
+61 613 9342 7348
Email
richard.verrelli@mh.org.au
First Name & Middle Initial & Last Name & Degree
Paul Anderson, MD
Facility Name
Urology Bay of Plenty
City
Tauranga
ZIP/Postal Code
3140
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rana Reuther, CRA
Phone
64 7 577 7795
Email
rana@urobop.co.nz
First Name & Middle Initial & Last Name & Degree
Peter Gilling, MD
Phone
64 7 579 0466
Email
peter@urobop.co.nz
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Zenflow Spring System EU Safety and Performance Study
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