The Zenflow Spring System Safety, Performance and Effectiveness Study (ZEST2)
Primary Purpose
Benign Prostatic Hyperplasia
Status
Active
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Zenflow Spring System
Sponsored by
About this trial
This is an interventional treatment trial for Benign Prostatic Hyperplasia
Eligibility Criteria
Inclusion Criteria:
All subjects are required to meet the following inclusion criteria in order to be considered eligible for participation in this trial:
- ≥ 45 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 and prostatic urethral length between 2.5-4.5 cm.
- Failed or intolerant to medication regimen for the treatment of LUTS.
Exclusion Criteria:
Subjects will be excluded from participating in this trial if they meet any of the following criteria:
- Obstructive intravesical median prostatic lobe or high bladder neck
- Urethral stricture, meatal stenosis, or bladder neck obstruction - either current, or recurrent requiring 2 or more dilatations
- Baseline PSA > 10 ng/mL or confirmed or suspected prostate cancer
- Elevated risk of prostate cancer
- Post-void residual volume (PVR) > 250 ml
- Peak urinary flow rate > 12 ml/second, with ≥ 125 ml voided volume at baseline
- History of chronic urinary retention
- History of neurogenic bladder
- Compromised renal function (e.g., serum creatinine > 1.8 mg/dl) due to bladder obstruction
- Concomitant Urinary Tract Infection (UTI) (subject can be enrolled following successful treatment of UTI and a clean urine test)
- Concomitant bladder stones
- Confirmed or suspected 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 24 months
- Use of concomitant medications (e.g., anticholinergics, antispasmodics or antidepressants) affecting bladder function
- Patients taking coumadin 3 days or less prior to procedure and have INR value > 1.5 on day of procedure. ASA and clopidogrel must be ceased 7 days prior to the procedure
- 5 alpha 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)
- alpha 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
Sites / Locations
- Hospital Regional de Alta Especialidad de Ixtapaluca
- Hospital Universitario "Dr. José Eleuterio González"
- Centro de Urología Avanzada del Noreste (CUAN)
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment Group
Arm Description
Receives treatment with the Zenflow Spring System
Outcomes
Primary Outcome Measures
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.
Need for urinary catheterization
Rate of extended post-operative urinary catheterization
Secondary Outcome Measures
Incidence of procedure or device related serious adverse events
Assessment of any device or procedure related Serious Adverse Events (SAE)
Assessment of Pain
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.
Assessment of Adverse Events
Rate of adverse events related to the procedure or device.
Assessment of Sexual Health: 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.
Assessment of Sexual Health: 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.
Effectiveness of the Spring Implant in reducing symptoms of Benign Prostatic Hyperplasia (BPH) by patient response to the International Prostate Symptom Score and Quality of Life Questionnaire (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 is 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.
Effectiveness of the Spring Implant in reducing symptoms of Benign Prostatic Hyperplasia (BPH)
Improvement in flow of urine
Repeat interventions to treat 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.
Increase or change in medications to treat Benign Prostatic Hyperplasia (BPH)
Incidence of increase in dosage, or initiation of new medication to treat symptoms of BPH.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03595735
Brief Title
The Zenflow Spring System Safety, Performance and Effectiveness Study
Acronym
ZEST2
Official Title
The Zenflow Spring System Safety, Performance and Effectiveness Study (ZEST2)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 21, 2018 (Actual)
Primary Completion Date
December 30, 2020 (Actual)
Study Completion Date
March 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zenflow, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a clinical evaluation to assess the safety and performance of the Zenflow Spring System when used as intended to relieve symptoms of obstructive Benign Prostatic Hyperplasia (BPH).
Detailed Description
A multi-center, prospective, single arm safety, performance, and effectiveness trial. The study will be conducted in two stages. Upon the successful completion of stage 1, the study will be expanded and continue to stage 2.
Stage 1 will enroll subjects in the Intent to Treat (ITT) cohort. The purpose of stage 1 is to assess acute safety and performance of the Zenflow System at the time of the procedure, through discharge, 2 weeks and 1 month, in up to 10 subjects enrolled at up to 7 investigational sites, to determine continuation to stage 2.
Upon successful completion of stage 1, the study will be expanded to stage 2 with sites added and continued enrollment in the ITT cohort. All subjects, including those enrolled in the stage 1 evaluation, will continue to be followed at all the designated follow-up time points for the full duration of the study (60 months).
Whether or not the study continues to Stage 2, all enrolled subjects will be followed for the entire duration of the study (60 months), or until exited.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Multi-center, prospective, single-arm.
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
Receives treatment with the Zenflow Spring System
Intervention Type
Device
Intervention Name(s)
Zenflow Spring System
Other Intervention Name(s)
Spring Implant
Intervention Description
The Zenflow Spring System consists of the Spring Delivery System with Implant, Spring Scope, Camera Control Unit (CCU), Measurement Tool, and Spring Retrieval Tool.
Primary Outcome Measure Information:
Title
Successful placement of the Zenflow Spring Implant
Description
Successful deployment and procedural success for the Zenflow System to implant the Spring device in the operating room or an out-patient clinical setting.
Time Frame
Day of discharge up to 7 days following device placement
Title
Need for urinary catheterization
Description
Rate of extended post-operative urinary catheterization
Time Frame
7 days after the procedure
Secondary Outcome Measure Information:
Title
Incidence of procedure or device related serious adverse events
Description
Assessment of any device or procedure related Serious Adverse Events (SAE)
Time Frame
Day of discharge up to 7 days following device placement
Title
Assessment of Pain
Description
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.
Time Frame
Baseline, 2 weeks, 1 month and 3 months
Title
Assessment of Adverse Events
Description
Rate of adverse events related to the procedure or device.
Time Frame
Up to 2 years
Title
Assessment of Sexual Health: Change in sexual health measured by change in the Sexual Health Inventory for Men (SHIM) questionnaire score
Description
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.
Time Frame
Baseline, 3, 6, 12, & 24 months
Title
Assessment of Sexual Health: Change in sexual health measured by change in ability to ejaculate using the Male Sexual Health Questionnaire - Ejaculatory domain (MSHQ-EjD)
Description
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.
Time Frame
Baseline, 3, 6, 12, & 24 months
Title
Effectiveness of the Spring Implant in reducing symptoms of Benign Prostatic Hyperplasia (BPH) by patient response to the International Prostate Symptom Score and Quality of Life Questionnaire (IPSS+QoL).
Description
The patient is asked to respond to 7 questions related to his urinary health using a rating scale of 0 to 5 where is 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.
Time Frame
Baseline, 2 weeks, 1, 6, 12, 24 months
Title
Effectiveness of the Spring Implant in reducing symptoms of Benign Prostatic Hyperplasia (BPH)
Description
Improvement in flow of urine
Time Frame
Baseline, 2 weeks, 1, 3, 6, 12, 24 months
Title
Repeat interventions to treat Benign Prostatic Hyperplasia (BPH)
Description
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.
Time Frame
Up to 2 years
Title
Increase or change in medications to treat Benign Prostatic Hyperplasia (BPH)
Description
Incidence of increase in dosage, or initiation of new medication to treat symptoms of BPH.
Time Frame
Up to 2 years
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All subjects are required to meet the following inclusion criteria in order to be considered eligible for participation in this trial:
≥ 45 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 and prostatic urethral length between 2.5-4.5 cm.
Failed or intolerant to medication regimen for the treatment of LUTS.
Exclusion Criteria:
Subjects will be excluded from participating in this trial if they meet any of the following criteria:
Obstructive intravesical median prostatic lobe or high bladder neck
Urethral stricture, meatal stenosis, or bladder neck obstruction - either current, or recurrent requiring 2 or more dilatations
Baseline PSA > 10 ng/mL or confirmed or suspected prostate cancer
Elevated risk of prostate cancer
Post-void residual volume (PVR) > 250 ml
Peak urinary flow rate > 12 ml/second, with ≥ 125 ml voided volume at baseline
History of chronic urinary retention
History of neurogenic bladder
Compromised renal function (e.g., serum creatinine > 1.8 mg/dl) due to bladder obstruction
Concomitant Urinary Tract Infection (UTI) (subject can be enrolled following successful treatment of UTI and a clean urine test)
Concomitant bladder stones
Confirmed or suspected 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 24 months
Use of concomitant medications (e.g., anticholinergics, antispasmodics or antidepressants) affecting bladder function
Patients taking coumadin 3 days or less prior to procedure and have INR value > 1.5 on day of procedure. ASA and clopidogrel must be ceased 7 days prior to the procedure
5 alpha 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)
alpha 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan J Galan, MD
Organizational Affiliation
Centro de Urología Avanzada del Noreste (CUAN)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Regional de Alta Especialidad de Ixtapaluca
City
Zoquiapan
State/Province
Ciudad de Ixtapaluca
ZIP/Postal Code
56530
Country
Mexico
Facility Name
Hospital Universitario "Dr. José Eleuterio González"
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Centro de Urología Avanzada del Noreste (CUAN)
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
66269
Country
Mexico
12. IPD Sharing Statement
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The Zenflow Spring System Safety, Performance and Effectiveness Study
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