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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03577236




Registration number
NCT03577236
Ethics application status
Date submitted
16/05/2018
Date registered
5/07/2018
Date last updated
29/10/2019

Titles & IDs
Public title
The Zenflow Spring System EU Safety and Performance Study
Scientific title
The Zenflow Spring System EU Safety and Performance Study
Secondary ID [1] 0 0
CLIN-0050
Universal Trial Number (UTN)
Trial acronym
ZEST EU
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Benign Prostatic Hyperplasia 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Zenflow Spring System

Experimental: Zenflow Spring System - Receives treatment with the investigational device


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

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Need for urinary catheterization - Rate of extended post-operative urinary catheterization
Timepoint [1] 0 0
7 days after the procedure
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
Day of discharge up to 7 days following device placement
Primary outcome [3] 0 0
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.
Timepoint [3] 0 0
Baseline and 3 months
Secondary outcome [1] 0 0
Incidence of procedure or device related serious adverse events - Assessment of any device or procedure related Serious Adverse Events (SAE)
Timepoint [1] 0 0
Up to 30 days
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
Baseline, 3, 6, 12, & 24 months
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
Baseline, 3, 6, 12, & 24 months
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
Baseline, 2 weeks, 1 month and 3 months
Secondary outcome [5] 0 0
Assessment of Adverse Events - Rate of adverse events related to the procedure or device.
Timepoint [5] 0 0
Up to 2 years
Secondary outcome [6] 0 0
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.
Timepoint [6] 0 0
Baseline, 2 weeks, 1, 6, 12, 24 months
Secondary outcome [7] 0 0
Effectiveness of the Spring Implant in reducing symptoms of Benign Prostatic Hyperplasia (BPH) - Improvement in flow of urine as measured by uroflowmetry machine.
Timepoint [7] 0 0
Baseline, 2 weeks, 1, 3, 6, 12, 24 months
Secondary outcome [8] 0 0
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.
Timepoint [8] 0 0
Up to 2 years

Eligibility
Key inclusion criteria
1. Patient is able and willing to comply with all the assessments of the study

2. 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

3. = 45 years of age

4. Baseline IPSS score > 13, and a baseline Quality of Life (QoL) question score > 3

5. 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

6. Failed, intolerant, or patient choice to not take a medication regimen for the
treatment of LUTS

7. Patient must meet ONE of the following criteria:

1. Baseline PSA <= 2.5ng/mL

2. Baseline PSA >2.5 ng/mL and <=10 ng/mL AND free PSA >=25% of total PSA (no biopsy
required or negative biopsy)

3. Baseline PSA >10ng/mL AND negative prostate biopsy1 result within 12 months

4. Negative prostate biopsy1 within 12 months if abnormal digital rectal examination

5. 3 Tesla MRI of the prostate, with normal findings, within 12 months prior to the
baseline visit
Minimum age
45 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1. Obstructive intravesical median prostatic lobe which, in the opinion of the
Investigator, would not benefit from treatment

2. Urethral stricture, meatal stenosis, or bladder neck obstruction - either current, or
recurrent requiring 2 or more dilations as reported in the patient's history

3. Requiring self-catheterization to void

4. Baseline PSA > 10 ng/mL or confirmed or suspected prostate cancer

5. Any of the following, taken from a single uroflowmetry reading:

1. Peak urinary flow rate > 12 ml/second

2. Post-void residual (PVR) > 250 ml

3. Peak Urinary flow rate of > 15 ml/second

4. < 125ml urinary volume voided at baseline (pre-bladder urinary volume of = 150 ml
required)

6. Other condition or disease that might cause urinary retention

7. History of other diseases causing voiding dysfunction

8. 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)

9. Concomitant bladder stones

10. Previous pelvic irradiation or radical pelvic surgery

11. Previous prostate surgery, stent implantations, laser prostatectomy, hyperthermia or
another invasive treatment to the prostate

12. Chronic prostatitis, or recurring prostatitis within the past 12 months

13. Known allergy to nickel

14. Life expectancy less than 24 months

15. Use of concomitant medications (e.g., anticholinergics, antispasmodics or
antidepressants) affecting bladder function

16. 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)

17. 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)

18. Taking one of the following within 2 weeks of pre-treatment (baseline) evaluation:

1. alpha-blockers,

2. androgens,

3. anticholinergics, or

4. cholinergic medication gonadotropin releasing hormonal analogs

19. Taking one of the following within 24 hours of pre-treatment (baseline) evaluation:

1. phenylephrine, or

2. pseudoephedrine

20. Future fertility concerns

21. Any severe illness that might prevent study completion or would confound study results

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Australian Clinical Trials - Wahroonga
Recruitment hospital [2] 0 0
South Coast Urology - Wollongong
Recruitment hospital [3] 0 0
Goldfields Urology - Bendigo
Recruitment hospital [4] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2076 - Wahroonga
Recruitment postcode(s) [2] 0 0
2500 - Wollongong
Recruitment postcode(s) [3] 0 0
3550 - Bendigo
Recruitment postcode(s) [4] 0 0
3050 - Melbourne
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Tauranga

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Zenflow, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/show/NCT03577236
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Peter Gilling, MD
Address 0 0
Tauranga Urology Research Ltd.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Debra Cogan, B.A., RN
Address 0 0
Country 0 0
Phone 0 0
+001 408 515-0820
Fax 0 0
Email 0 0
dcogan@zenflow.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03577236