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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03577236
Ethics application status
Date submitted
16/05/2018
Date registered
5/07/2018

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
Timepoint [1] 0 0
7 days after the procedure
Primary outcome [2] 0 0
Successful placement of the Zenflow Spring Implant
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)
Timepoint [3] 0 0
Baseline and 3 months
Secondary outcome [1] 0 0
Incidence of procedure or device related serious adverse events
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
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)
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
Timepoint [4] 0 0
Baseline, 2 weeks, 1 month and 3 months
Secondary outcome [5] 0 0
Assessment of Adverse Events
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)
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)
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)
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
Sex
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
Not applicable
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
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/01/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/05/2024
Actual
Sample size
Target
50
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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03577236