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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02786290




Registration number
NCT02786290
Ethics application status
Date submitted
9/05/2016
Date registered
30/05/2016

Titles & IDs
Public title
The Zenflow Spring System Feasibility and Safety Study
Scientific title
The Zenflow Spring System Feasibility and Safety Study (ZEST)
Secondary ID [1] 0 0
CLIN-0002
Universal Trial Number (UTN)
Trial acronym
ZEST
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: Treatment Group - Receives intervention with the Zenflow Spring System.


Treatment: Devices: Zenflow Spring System
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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Intraoperative
Primary outcome [2] 0 0
Occurrence of device and/or procedure related Adverse Events as determined by investigator and independent medical reviewer
Timepoint [2] 0 0
Intraoperative
Primary outcome [3] 0 0
Occurrence of Adverse Event specific to indwelling catheterization, descriptive analysis
Timepoint [3] 0 0
Seven days following implantation of the investigational device
Primary outcome [4] 0 0
Effectiveness of implant measured through symptom improvement (International Prostate Symptom Score - IPSS)
Timepoint [4] 0 0
3 months following device placement
Secondary outcome [1] 0 0
Assessment of Sexual Health using the Sexual Health in Men (SHIM) questionnaire
Timepoint [1] 0 0
6 months, 12-,24-,36-, months post implantation
Secondary outcome [2] 0 0
Assessment of Incontinence, using the Incontinence Severity Index (ISI) questionnaire
Timepoint [2] 0 0
2 weeks, 1 month, 3 months
Secondary outcome [3] 0 0
Observation of pain using a validated Visual Analogue Scale (VAS) questionnaire
Timepoint [3] 0 0
through 3 month follow-up
Secondary outcome [4] 0 0
Improvement in Uroflowmetry compared to baseline
Timepoint [4] 0 0
3-, 6-, 12-, 24-, 36-months post implantation
Secondary outcome [5] 0 0
Effectiveness of implant measured through symptom improvement (International Prostate Symptom Score - IPSS)
Timepoint [5] 0 0
12 months 24 months and 36 months
Secondary outcome [6] 0 0
Effectiveness of the treatment by assessing need for further treatment to alleviate symptoms of BPH.
Timepoint [6] 0 0
12 months 24 months and 36 months

Eligibility
Key inclusion criteria
1. 50 to 80 years of age
2. Baseline IPSS score > 13, and a baseline Quality of Life (Qol) question score > 3
3. Prostate volume 25 - 80 cc by Trans Rectal Ultrasound (TRUS), measured within past 90 days
4. 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.
5. Failed or intolerant to medication regimen for the treatment of LUTS.
Minimum age
50 Years
Maximum age
80 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
New Zealand only: A maximum of 5 participants in acute or chronic urinary retention may be included in the study provided they meet other entry criteria. Exclusion exemptions for these patients are described in 4a, 5a and they are exempt from #6.

Participants will be excluded from participating in this trial if they meet any of the following criteria:

1. Obstructive median prostatic lobe or high bladder neck
2. Urethral stricture, meatal stenosis, or bladder neck obstruction - either current, or recurrent requiring 2 or more dilatations
3. 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
4. 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)
5. 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)
6. History of chronic urinary retention. (New Zealand Only, up to 5 patients)
7. History of neurogenic bladder
8. Compromised renal function (e.g., serum creatinine > 1.8 mg/dl)
9. Concomitant Urinary Tract Infection (UTI)
10. Concomitant bladder stones
11. Confirmed or suspected prostate/bladder cancer
12. Previous pelvic irradiation or radical pelvic surgery
13. Previous prostate surgery, stent implantations, laser prostatectomy, hyperthermia or another invasive treatment to the prostate
14. Chronic prostatitis, or recurring prostatitis within the past 12 months
15. Serious concurrent medical conditions such as uncontrolled diabetes
16. Known allergy to nickel
17. Life expectancy less than 12 months
18. Use of concomitant medications (e.g., anticholinergics, antispasmodics or antidepressants) affecting bladder function
19. Anti-coagulant, anti-platelet, or thrombolytic medication other than Acetylsalicylic Acid (ASA) or Clopidogrel. ASA and Clopidogrel must be ceased 7 days prior to the procedure.
20. 5--reductase inhibitors within 6 months of pre-treatment 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 for entrance into or throughout the study).
21. -blockers within 2 weeks of pre-treatment 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 for entrance into or throughout the study).
22. Future fertility concerns
23. Any severe illness that might prevent study completion or would confound study results

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
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
NA
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
1/04/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2020
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Bulgaria
State/province [1] 0 0
Sofia
Country [2] 0 0
New Zealand
State/province [2] 0 0
Nelson
Country [3] 0 0
New Zealand
State/province [3] 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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
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/NCT02786290