Benign Prostatic HyperplasiaZESTNCT02786290
The Zenflow Spring System Feasibility and Safety Study
A study testing Zenflow Spring System in people with Benign Prostatic Hyperplasia, run by Zenflow, Inc. at 3 sites in 2 countries.
Trial summary
This is a First in Human study to assess the feasibility, safety and effectiveness of the Zenflow Spring System in relieving the symptoms of obstructive Benign Prostatic Hyperplasia (BPH). Read more about this study
- Who is it for?
- Ages 50 to 80 years, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Zenflow Spring System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Apr 2016to Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 50 to 80 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), measured within past 90 days
- 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.
- Failed or intolerant to medication regimen for the treatment of LUTS.
Who cannot join
- 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:
- Obstructive median prostatic lobe or high bladder neck
- Urethral stricture, meatal stenosis, or bladder neck obstruction - either current, or recurrent requiring 2 or more dilatations
- 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
- 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)
Show all 25Show fewer
- 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)
- History of chronic urinary retention. (New Zealand Only, up to 5 patients)
- History of neurogenic bladder
- Compromised renal function (e.g., serum creatinine > 1.8 mg/dl)
- Concomitant Urinary Tract Infection (UTI)
- Concomitant bladder stones
- Confirmed or suspected prostate/bladder cancer
- 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
- Serious concurrent medical conditions such as uncontrolled diabetes
- Known allergy to nickel
- Life expectancy less than 12 months
- Use of concomitant medications (e.g., anticholinergics, antispasmodics or antidepressants) affecting bladder function
- 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.
- 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).
- -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).
- Future fertility concerns
- Any severe illness that might prevent study completion or would confound study results
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
New Zealand2 sites
RoundHay Medical Center
Nelson South, Nelson Region, 7010
Tauranga Urology Research Ltd
Tauranga, 3140
About this study
Official title: The Zenflow Spring System Feasibility and Safety Study (ZEST)
This is a First in Human study to assess the feasibility, safety and effectiveness of the Zenflow Spring System in relieving the symptoms of obstructive Benign Prostatic Hyperplasia (BPH).
Read the detailed description
The purpose of the Zenflow Study is to evaluate the feasibility and safety of a novel prostatic 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). Effectiveness will also be measured. It is intended that the features of the Zenflow Spring will provide an effective office-based treatment and management therapy for BPH with little or no side effects.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Zenflow Spring System
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zenflow Spring SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Receives intervention with the Zenflow Spring System. Receives: Device: Zenflow Spring System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Frequency of Device Success is assessed by subject, for both successful device placement in the target anatomy and absence of serious or unanticipated adverse events through discharge.
Measured: Intraoperative
Occurrence of device and/or procedure related Adverse Events as determined by investigator and independent medical reviewer
Frequency and severity of any device or procedure related adverse events, by subject.
Measured: Intraoperative
Occurrence of Adverse Event specific to indwelling catheterization, descriptive analysis
Frequency of indwelling catheterization = or > 7 days following placement of the investigational device.
Measured: Seven days following implantation of the investigational device
Effectiveness of implant measured through symptom improvement (International Prostate Symptom Score - IPSS)
Subjects should demonstrate improvement of > or = to 3 point reduction from baseline measurement.
Measured: 3 months following device placement
Secondary outcomes (6)
Assessment of Sexual Health using the Sexual Health in Men (SHIM) questionnaire
Observational assessment of subject scores on SHIM at the 6 months and 12 months visit, compared to baseline.
Measured: 6 months, 12-,24-,36-, months post implantation
Assessment of Incontinence, using the Incontinence Severity Index (ISI) questionnaire
Observational assessment of subject scores on ISI at 2 weeks, 1 month and 3 months compared to baseline.
Measured: 2 weeks, 1 month, 3 months
Observation of pain using a validated Visual Analogue Scale (VAS) questionnaire
Observational assessment of subject reports of pain on the VAS questionnaire, at discharge and follow up visits up to 3 months, compared to baseline.
Measured: through 3 month follow-up
Improvement in Uroflowmetry compared to baseline
Uroflowmetry is measured at 3 months post implantation and compared to baseline
Measured: 3-, 6-, 12-, 24-, 36-months post implantation
Effectiveness of implant measured through symptom improvement (International Prostate Symptom Score - IPSS)
Observation of IPSS scores compared to baseline at 12 months follow up.
Measured: 12 months 24 months and 36 months
Effectiveness of the treatment by assessing need for further treatment to alleviate symptoms of BPH.
Observation of incidence of repeat invasive treatment for LUTS through 12 months post-procedure
Measured: 12 months 24 months and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2019 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zenflow, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Gilling, MD, Principal investigator, Tauranga Urology Research Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02786290
- Sponsor's protocol ID
- CLIN-0002
- Acronym
- ZEST
- Status last verified
- Feb 2019
- First submitted
- 9 May 2016
- Last updated
- 6 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Charles J, Valenti L, Britt H. BPH - management in general practice. Aust Fam Physician. 2011 Oct;40(10):757.
PubMed 22003475Woo HH, Gillman MP, Gardiner R, Marshall V, Lynch WJ. A practical approach to the management of lower urinary tract symptoms among men. Med J Aust. 2011 Jul 4;195(1):34-9. doi: 10.5694/j.1326-5377.2011.tb03185.x.
PubMed 21728939Milani S, Djavan B. Lower urinary tract symptoms suggestive of benign prostatic hyperplasia: latest update on alpha-adrenoceptor antagonists. BJU Int. 2005 Jun;95 Suppl 4:29-36. doi: 10.1111/j.1464-410X.2005.05485.x.
PubMed 15871733Schelin S, Geertsen U, Walter S, Spangberg A, Duelund-Jacobsen J, Kroyer K, Hjertberg H, Vatne V, Richthoff J, Nordling J. Feedback microwave thermotherapy versus TURP/prostate enucleation surgery in patients with benign prostatic hyperplasia and persistent urinary retention: a prospective, randomized, controlled, multicenter study. Urology. 2006 Oct;68(4):795-9. doi: 10.1016/j.urology.2006.05.020.
PubMed 17070355Bruskewitz RC, Larsen EH, Madsen PO, Dorflinger T. 3-year followup of urinary symptoms after transurethral resection of the prostate. J Urol. 1986 Sep;136(3):613-5. doi: 10.1016/s0022-5347(17)44991-3.
PubMed 2426477Thomas JA, Tubaro A, Barber N, d'Ancona F, Muir G, Witzsch U, Grimm MO, Benejam J, Stolzenburg JU, Riddick A, Pahernik S, Roelink H, Ameye F, Saussine C, Bruyere F, Loidl W, Larner T, Gogoi NK, Hindley R, Muschter R, Thorpe A, Shrotri N, Graham S, Hamann M, Miller K, Schostak M, Capitan C, Knispel H, Bachmann A. A Multicenter Randomized Noninferiority Trial Comparing GreenLight-XPS Laser Vaporization of the Prostate and Transurethral Resection of the Prostate for the Treatment of Benign Prostatic Obstruction: Two-yr Outcomes of the GOLIATH Study. Eur Urol. 2016 Jan;69(1):94-102. doi: 10.1016/j.eururo.2015.07.054. Epub 2015 Aug 15.
PubMed 26283011Reich O, Gratzke C, Bachmann A, Seitz M, Schlenker B, Hermanek P, Lack N, Stief CG; Urology Section of the Bavarian Working Group for Quality Assurance. Morbidity, mortality and early outcome of transurethral resection of the prostate: a prospective multicenter evaluation of 10,654 patients. J Urol. 2008 Jul;180(1):246-9. doi: 10.1016/j.juro.2008.03.058. Epub 2008 May 21.
PubMed 18499179Mandeville J, Gnessin E, Lingeman JE. New advances in benign prostatic hyperplasia: laser therapy. Curr Urol Rep. 2011 Feb;12(1):56-61. doi: 10.1007/s11934-010-0153-1.
PubMed 21088938Ahyai SA, Lehrich K, Kuntz RM. Holmium laser enucleation versus transurethral resection of the prostate: 3-year follow-up results of a randomized clinical trial. Eur Urol. 2007 Nov;52(5):1456-63. doi: 10.1016/j.eururo.2007.04.053. Epub 2007 Apr 25.
PubMed 17499427Bachmann A, Tubaro A, Barber N, d'Ancona F, Muir G, Witzsch U, Grimm MO, Benejam J, Stolzenburg JU, Riddick A, Pahernik S, Roelink H, Ameye F, Saussine C, Bruyere F, Loidl W, Larner T, Gogoi NK, Hindley R, Muschter R, Thorpe A, Shrotri N, Graham S, Hamann M, Miller K, Schostak M, Capitan C, Knispel H, Thomas JA. 180-W XPS GreenLight laser vaporisation versus transurethral resection of the prostate for the treatment of benign prostatic obstruction: 6-month safety and efficacy results of a European Multicentre Randomised Trial--the GOLIATH study. Eur Urol. 2014 May;65(5):931-42. doi: 10.1016/j.eururo.2013.10.040. Epub 2013 Nov 11.
PubMed 24331152Gao YA, Huang Y, Zhang R, Yang YD, Zhang Q, Hou M, Wang Y. Benign prostatic hyperplasia: prostatic arterial embolization versus transurethral resection of the prostate--a prospective, randomized, and controlled clinical trial. Radiology. 2014 Mar;270(3):920-8. doi: 10.1148/radiol.13122803. Epub 2013 Nov 13.
PubMed 24475799Bouza C, Lopez T, Magro A, Navalpotro L, Amate JM. Systematic review and meta-analysis of Transurethral Needle Ablation in symptomatic Benign Prostatic Hyperplasia. BMC Urol. 2006 Jun 21;6:14. doi: 10.1186/1471-2490-6-14.
PubMed 16790044Roehrborn CG, Rukstalis DB, Barkin J, Gange SN, Shore ND, Giddens JL, Bolton DM, Cowan BE, Cantwell AL, McVary KT, Te AE, Gholami SS, Moseley WG, Chin PT, Dowling WT, Freedman SJ, Incze PF, Coffield KS, Borges FD, Rashid P. Three year results of the prostatic urethral L.I.F.T. study. Can J Urol. 2015 Jun;22(3):7772-82.
PubMed 26068624Peyton CC, Badlani GH. The management of prostatic obstruction with urethral stents. Can J Urol. 2015 Oct;22 Suppl 1:75-81.
PubMed 26497347Oesterling JE. A permanent, epithelializing stent for the treatment of benign prostatic hyperplasia. Preliminary results. J Androl. 1991 Nov-Dec;12(6):423-8.
PubMed 1722799
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Zenflow Spring System Feasibility and Safety Study (ZEST)
- ClinicalTrials.gov ID
- NCT02786290
- Acronym / sponsor ID
- ZEST / CLIN-0002
- Conditions
- Benign Prostatic Hyperplasia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Zenflow, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 30 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a First in Human study to assess the feasibility, safety and effectiveness of the Zenflow Spring System in relieving the symptoms of obstructive Benign Prostatic Hyperplasia (BPH).
Detailed description
The purpose of the Zenflow Study is to evaluate the feasibility and safety of a novel prostatic 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). Effectiveness will also be measured. It is intended that the features of the Zenflow Spring will provide an effective office-based treatment and management therapy for BPH with little or no side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: Zenflow Spring SystemReceives intervention with the Zenflow Spring System. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 50 to 80 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), measured within past 90 days
- 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.
- Failed or intolerant to medication regimen for the treatment of LUTS.
Key exclusion criteria (25 listed)
- 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:
- Obstructive median prostatic lobe or high bladder neck
- Urethral stricture, meatal stenosis, or bladder neck obstruction - either current, or recurrent requiring 2 or more dilatations
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zenflow Spring SystemThe 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. | Device | Treatment Group |
Primary outcome
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.
Time frame: Intraoperative
Frequency of Device Success is assessed by subject, for both successful device placement in the target anatomy and absence of serious or unanticipated adverse events through discharge.
Occurrence of device and/or procedure related Adverse Events as determined by investigator and independent medical reviewer
Time frame: Intraoperative
Frequency and severity of any device or procedure related adverse events, by subject.
Occurrence of Adverse Event specific to indwelling catheterization, descriptive analysis
Time frame: Seven days following implantation of the investigational device
Frequency of indwelling catheterization = or > 7 days following placement of the investigational device.
Effectiveness of implant measured through symptom improvement (International Prostate Symptom Score - IPSS)
Time frame: 3 months following device placement
Subjects should demonstrate improvement of > or = to 3 point reduction from baseline measurement.
6 secondary outcomes
Assessment of Sexual Health using the Sexual Health in Men (SHIM) questionnaire
Time frame: 6 months, 12-,24-,36-, months post implantation
Assessment of Incontinence, using the Incontinence Severity Index (ISI) questionnaire
Time frame: 2 weeks, 1 month, 3 months
Observation of pain using a validated Visual Analogue Scale (VAS) questionnaire
Time frame: through 3 month follow-up
Improvement in Uroflowmetry compared to baseline
Time frame: 3-, 6-, 12-, 24-, 36-months post implantation
Effectiveness of implant measured through symptom improvement (International Prostate Symptom Score - IPSS)
Time frame: 12 months 24 months and 36 months
Effectiveness of the treatment by assessing need for further treatment to alleviate symptoms of BPH.
Time frame: 12 months 24 months and 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2019.
- Background: PubMed 22003475Charles J, Valenti L, Britt H. BPH - management in general practice. Aust Fam Physician. 2011 Oct;40(10):757.
- Background: PubMed 21728939Woo HH, Gillman MP, Gardiner R, Marshall V, Lynch WJ. A practical approach to the management of lower urinary tract symptoms among men. Med J Aust. 2011 Jul 4;195(1):34-9. doi: 10.5694/j.1326-5377.2011.tb03185.x.
- Background: PubMed 15871733Milani S, Djavan B. Lower urinary tract symptoms suggestive of benign prostatic hyperplasia: latest update on alpha-adrenoceptor antagonists. BJU Int. 2005 Jun;95 Suppl 4:29-36. doi: 10.1111/j.1464-410X.2005.05485.x.
- Background: PubMed 17070355Schelin S, Geertsen U, Walter S, Spangberg A, Duelund-Jacobsen J, Kroyer K, Hjertberg H, Vatne V, Richthoff J, Nordling J. Feedback microwave thermotherapy versus TURP/prostate enucleation surgery in patients with benign prostatic hyperplasia and persistent urinary retention: a prospective, randomized, controlled, multicenter study. Urology. 2006 Oct;68(4):795-9. doi: 10.1016/j.urology.2006.05.020.
- Background: PubMed 2426477Bruskewitz RC, Larsen EH, Madsen PO, Dorflinger T. 3-year followup of urinary symptoms after transurethral resection of the prostate. J Urol. 1986 Sep;136(3):613-5. doi: 10.1016/s0022-5347(17)44991-3.
- Background: PubMed 26283011Thomas JA, Tubaro A, Barber N, d'Ancona F, Muir G, Witzsch U, Grimm MO, Benejam J, Stolzenburg JU, Riddick A, Pahernik S, Roelink H, Ameye F, Saussine C, Bruyere F, Loidl W, Larner T, Gogoi NK, Hindley R, Muschter R, Thorpe A, Shrotri N, Graham S, Hamann M, Miller K, Schostak M, Capitan C, Knispel H, Bachmann A. A Multicenter Randomized Noninferiority Trial Comparing GreenLight-XPS Laser Vaporization of the Prostate and Transurethral Resection of the Prostate for the Treatment of Benign Prostatic Obstruction: Two-yr Outcomes of the GOLIATH Study. Eur Urol. 2016 Jan;69(1):94-102. doi: 10.1016/j.eururo.2015.07.054. Epub 2015 Aug 15.
- Background: PubMed 18499179Reich O, Gratzke C, Bachmann A, Seitz M, Schlenker B, Hermanek P, Lack N, Stief CG; Urology Section of the Bavarian Working Group for Quality Assurance. Morbidity, mortality and early outcome of transurethral resection of the prostate: a prospective multicenter evaluation of 10,654 patients. J Urol. 2008 Jul;180(1):246-9. doi: 10.1016/j.juro.2008.03.058. Epub 2008 May 21.
- Background: PubMed 21088938Mandeville J, Gnessin E, Lingeman JE. New advances in benign prostatic hyperplasia: laser therapy. Curr Urol Rep. 2011 Feb;12(1):56-61. doi: 10.1007/s11934-010-0153-1.
- Background: PubMed 17499427Ahyai SA, Lehrich K, Kuntz RM. Holmium laser enucleation versus transurethral resection of the prostate: 3-year follow-up results of a randomized clinical trial. Eur Urol. 2007 Nov;52(5):1456-63. doi: 10.1016/j.eururo.2007.04.053. Epub 2007 Apr 25.
- Background: PubMed 24331152Bachmann A, Tubaro A, Barber N, d'Ancona F, Muir G, Witzsch U, Grimm MO, Benejam J, Stolzenburg JU, Riddick A, Pahernik S, Roelink H, Ameye F, Saussine C, Bruyere F, Loidl W, Larner T, Gogoi NK, Hindley R, Muschter R, Thorpe A, Shrotri N, Graham S, Hamann M, Miller K, Schostak M, Capitan C, Knispel H, Thomas JA. 180-W XPS GreenLight laser vaporisation versus transurethral resection of the prostate for the treatment of benign prostatic obstruction: 6-month safety and efficacy results of a European Multicentre Randomised Trial--the GOLIATH study. Eur Urol. 2014 May;65(5):931-42. doi: 10.1016/j.eururo.2013.10.040. Epub 2013 Nov 11.
- Background: PubMed 24475799Gao YA, Huang Y, Zhang R, Yang YD, Zhang Q, Hou M, Wang Y. Benign prostatic hyperplasia: prostatic arterial embolization versus transurethral resection of the prostate--a prospective, randomized, and controlled clinical trial. Radiology. 2014 Mar;270(3):920-8. doi: 10.1148/radiol.13122803. Epub 2013 Nov 13.
- Background: PubMed 16790044Bouza C, Lopez T, Magro A, Navalpotro L, Amate JM. Systematic review and meta-analysis of Transurethral Needle Ablation in symptomatic Benign Prostatic Hyperplasia. BMC Urol. 2006 Jun 21;6:14. doi: 10.1186/1471-2490-6-14.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Gilling, MD principal investigator
Tauranga Urology Research Ltd.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zenflow Spring System in people with Benign Prostatic Hyperplasia, run by Zenflow, Inc. at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in New Zealand, Bulgaria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Intraoperative). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02786290, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2019.