The Zenflow Spring System Feasibility and Safety Study (ZEST)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02786290|
Recruitment Status : Active, not recruiting
First Posted : May 30, 2016
Last Update Posted : February 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Benign Prostatic Hyperplasia||Device: Zenflow Spring System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Zenflow Spring System Feasibility and Safety Study (ZEST)|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||January 2020|
Experimental: Treatment Group
Receives intervention with the Zenflow Spring System.
Device: 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.
- 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.
- Assessment of Sexual Health using the Sexual Health in Men (SHIM) questionnaire [ Time Frame: 6 months, 12-,24-,36-, months post implantation ]Observational assessment of subject scores on SHIM at the 6 months and 12 months visit, compared to baseline.
- Assessment of Incontinence, using the Incontinence Severity Index (ISI) questionnaire [ Time Frame: 2 weeks, 1 month, 3 months ]Observational assessment of subject scores on ISI at 2 weeks, 1 month and 3 months compared to baseline.
- Observation of pain using a validated Visual Analogue Scale (VAS) questionnaire [ Time Frame: through 3 month follow-up ]Observational assessment of subject reports of pain on the VAS questionnaire, at discharge and follow up visits up to 3 months, compared to baseline.
- Improvement in Uroflowmetry compared to baseline [ Time Frame: 3-, 6-, 12-, 24-, 36-months post implantation ]Uroflowmetry is measured at 3 months post implantation and compared to baseline
- Effectiveness of implant measured through symptom improvement (International Prostate Symptom Score - IPSS) [ Time Frame: 12 months 24 months and 36 months ]Observation of IPSS scores compared to baseline at 12 months follow up.
- Effectiveness of the treatment by assessing need for further treatment to alleviate symptoms of BPH. [ Time Frame: 12 months 24 months and 36 months ]Observation of incidence of repeat invasive treatment for LUTS through 12 months post-procedure
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02786290
|MBAL "Tokuda Bolnitsa Sofia" AD|
|Sofia, Bulgaria, 1407|
|RoundHay Medical Center|
|Nelson South, Nelson, New Zealand, 7010|
|Tauranga Urology Research Ltd|
|Tauranga, New Zealand, 3140|
|Principal Investigator:||Peter Gilling, MD||Tauranga Urology Research Ltd.|