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Safety and Effectiveness Study of the Zenflow Spring System (BREEZE)

Primary Purpose

BPH (Benign Prostatic Hyperplasia), Lower Urinary Tract Symptoms (LUTS)

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Zenflow Spring System
Sham Procedure
Sponsored by
Zenflow, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for BPH (Benign Prostatic Hyperplasia)

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subject is able and willing to comply with all the assessments of the study,
  2. Subject or subject'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; ≥ 1 in the IPSS voiding to storage sub-score ratio (IPSS-V/S),
  5. Prostate volume 25 - 80 cc by transrectal ultrasound (TRUS), measured within 120 days post study consent,
  6. Prostatic urethral length between 25 and 45 mm, as measured by cystoscopic pull-back,
  7. Failed, intolerant, or subject choice to not take a medication regimen for the treatment of LUTS.

Exclusion Criteria:

  1. Obstructive intravesical median prostatic lobe as determined by ultrasound (i.e., more than 10 mm intravesical prostatic protrusion on sagittal mid-prostate plane via abdominal ultrasound),
  2. High bladder neck with the absence of lateral lobe encroachment indicating a high likelihood of primary bladder neck obstruction as determined by the Investigator,
  3. Urethral stricture, meatal stenosis, or bladder neck stricture - either current or recurrent,
  4. Anatomical anomalies that will not accommodate the Implant, as determined by cystoscopy (e.g., prostatic urethral length to height geometry),
  5. Requires indwelling catheter or intermittent catheterization to void,
  6. Baseline PSA > 10 ng/mL or confirmed or suspected prostate cancer (Subjects with a PSA level above 2.5 ng/mL, or age specific, or local reference ranges should have prostate cancer excluded to the Investigator's satisfaction),
  7. One of the following baseline test results, taken from a single uroflowmetry reading:

    1. Urinary volume void ≤ 125mL (pre-bladder urinary volume of ≥ 150 mL required),
    2. Peak urinary flow rate (Qmax) of ≤ 5 ml/second or > 15 mL/second,
    3. Post- void residual volume (PVR) > 250 mL
  8. History of other diseases causing voiding dysfunction including urinary retention (e.g., uncontrolled diabetes, diagnosis of neurogenic bladder, Parkinson's disease, multiple sclerosis, etc.),
  9. Subjects with overactive bladder in the absence of benign prostatic obstruction,
  10. Acute urinary tract infection (UTI) or finding of asymptomatic bacteriuria (Note: subject can be enrolled if the UTI is treated and followed with a negative urine test result), or subjects with history of recurrent UTIs (defined as > 3 UTIs in the past 12 months),
  11. Concomitant bladder stones,
  12. Previous pelvic irradiation or radical pelvic surgery,
  13. Previous prostate surgery, including: enucleation, resection, vaporization, thermotherapy, ablation, stenting or prostatic urethral lift,
  14. Chronic prostatitis, recurrent prostatitis, chronic pelvic pain syndrome (CPPS), or painful bladder syndrome within the past 12 months
  15. Known allergy to nickel,
  16. Life expectancy less than 60 months,
  17. Use of concomitant medications (e.g., anticholinergics, antispasmodics or tricyclic antidepressants) affecting bladder function,
  18. 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 (Note: low dose aspirin therapy (81 mg) is permitted),
  19. Taking 5-alpha-reductase inhibitors within 3 months of baseline evaluation,
  20. Taking one of the following within 2 weeks of baseline evaluation:

    1. alpha-blockers,
    2. imipramine,
    3. anticholinergics,
    4. cholinergic gonadotropin releasing hormonal analogues,
    5. Phosphodiesterase-5 Enzyme Inhibitors (Tadalafil) in doses for BPH,
    6. Beta-3 adrenergic receptor agonist (Mirabegron),
  21. Taking androgens, unless eugonadal state for at least 3 months or greater as documented by the Investigator,
  22. Taking one of the following within 24 hours of pre-treatment (baseline) evaluation:

    1. phenylephrine, or,
    2. pseudoephedrine,
  23. Future fertility concerns, or,
  24. In the Investigator's opinion, the subject has a physical, psychological, or medical impairment that might prevent study completion or would confound study results (including subject questionnaires).

Sites / Locations

  • American Institute of Research
  • Northshore University Health SystemRecruiting
  • Sheldon Freedman, MD, LTD
  • Carolina Urologic Research AssociatesRecruiting
  • Midtown Urology AssociatesRecruiting
  • Urology Austin, PLLCRecruiting
  • Urology of Virginia, PLLCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Active Comparator

Sham Comparator

Other

Arm Label

Roll-in Cohort

Treatment Arm

Control Arm

Crossover Cohort

Arm Description

Each Investigator will be allowed to treat up to 3 roll-in subjects with the Spring Implant prior to initiation of randomization. Roll-in patients will be followed for 60 months.

Includes all patients who are randomized and start the treatment procedure. During the procedure the patient will be shielded from the treatment area and cystoscopy screen. The patient and site personnel administering follow-up assessments will be blinded to the study arm through the 3-month follow-up visit. Unblinding will occur at 3 months post-procedure after the assessments are completed. Follow up will continue for 60 months.

Includes all patients who receive a sham procedure. Patients will be shielded from the treatment area and cystoscopy screen. A Foley Catheter is placed into the patient's bladder and inflated. Additionally, devices will be used to produce mock deployment sounds of the Zenflow procedure. Once complete, the balloon will be deflated and the catheter will be removed, completing the procedure. Control arm subjects are followed for 3 months and exited from the study unless they elect and qualify for Crossover.

Control Arm (Sham) patients can receive treatment with the Zenflow Spring System after their 3-month follow-up assessments are completed, and their symptoms warrant treatment and enrollment criteria are met. The study visit follow-up schedule will restart and the subject will be followed for 60 months post Zenflow Spring implantation. Unless treated with the Spring System, the subject will be exited from the study once they have completed their 3-month follow-up visit.

Outcomes

Primary Outcome Measures

Safety - The need for urinary catheterization
The rate of extended post-operative urinary catheterization (> 7 days from treatment) for inability to void among patients treated with the Zenflow Spring System.
Safety - Adverse Events
The rate of device or procedure related serious adverse events in both the Treatment Arm and the Sham Arm.
Effectiveness of the Spring Implant in reducing symptoms of Benign Prostatic Hyperplasia (BPH) as compared to Sham
The Treatment Arm will be considered superior to the Control Arm (Sham) when the mean 3-month improvement from baseline score for the IPSS symptom questionnaire demonstrates a minimum statistical margin of 25% compared to mean improvement from baseline for the Control Arm (Sham) alone.
Effectiveness- Symptoms Improvement
The mean percent change in IPSS in the treatment arm is at least 30% improvement over the Patient's pre-treatment baseline score.

Secondary Outcome Measures

Safety - Adverse Events
Rate of device or procedure related adverse events at all time points.
Safety - Pain Assessment Questionnaire
Comparison of pain at discharge to 2-week, 1- and, 3-month follow-up visits per Visual Analogue Scale (VAS) questionnaire. The VAS questionnaire asks the patient to indicate on a scale of 1 to 10 his level of pain where 1 is no pain and 10 is the worst pain.
Safety - Sexual Health Questionnaire 1
Change in sexual health characterized by the questionnaire Sexual Health Inventory for Men (SHIM).
Safety - Sexual Health Questionnaire 2
Change in sexual health characterized by questionnaire Male Sexual Health Questionnaire - Ejaculatory Domain (MSHQ-EjD)
Safety - Device Removal
Assessment of adverse events outcomes related to a Spring Implant removal procedure.
Safety - Classification of Adverse Events
Proportion of patients with adverse events classified as Clavien-Dindo Grade IIIb or higher or any event resulting in persistent disability
Effectiveness - long term symptom improvement 1
Percent of patients who experience at least a 30 percent improvement in IPSS from their baseline pre-treatment score
Effectiveness - long term symptom improvement 2
Mean percent change in IPSS in the treatment arm compared to baseline at all timepoints other than the primary endpoints.
Effectiveness - flow metrics
Change from baseline in uroflowmetry measures of peak flow rate (Qmax)
Effectiveness - Re-intervention (device)
Post-procedure incidence of secondary reintervention using an alternate surgical LUTS therapy.
Effectiveness - Re-intervention (drug)
Post-procedure incidence of secondary reintervention using standard pharmacological agents for LUTS therapy.

Full Information

First Posted
July 13, 2021
Last Updated
June 7, 2023
Sponsor
Zenflow, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04987138
Brief Title
Safety and Effectiveness Study of the Zenflow Spring System
Acronym
BREEZE
Official Title
Safety and Effectiveness Study of the Zenflow Spring System - A Minimally Invasive Treatment for LUTS Associated With BPH
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 30, 2021 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
June 2026 (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
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Evaluate the safety and effectiveness of the Zenflow Spring System in relieving LUTS associated with BPH.
Detailed Description
Prospective, multi-center, multinational, 2:1 randomized, single-blinded, controlled clinical trial of the Zenflow Spring System. Patients randomized to the treatment group will undergo Zenflow Spring placement. Patients randomized to the control group will undergo a Sham procedure. Patients and site personnel administering follow-up assessments will be blinded to the randomized treatment through completion of the 3-month follow-up visit. Once a patient has completed their 3-month follow-up assessments, they will be unblinded. Following unblinding, patients who received a Sham procedure may elect to receive treatment with the Zenflow Spring System or alternatively they may exit the study. The duration of study participation is 60 months for patients who receive a Spring Implant and 3 months for subjects in the Control Arm.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
BPH (Benign Prostatic Hyperplasia), Lower Urinary Tract Symptoms (LUTS)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Prospective, multi-center, multinational, 2:1 randomized, single-blinded, controlled clinical trial of the Zenflow Spring System. Following unblinding, control patients may elect to receive treatment with the Zenflow Spring System or exit the study.
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
The patient and site personnel administering follow-up assessments to 3 months will be blinded to the study assignment. Unblinding will occur at 3 months post procedure after follow-up assessments are completed. All patients will be asked post-treatment if they believe they are in the Treatment Arm, Control Arm, or do not know. The blinding questionnaire will be administered at discharge and at the 1-month and 3-month follow-up assessments. Control Arm patients can receive treatment with the Zenflow Spring System within 30 days after their 3-month follow-up assessments are completed, and their symptoms warrant treatment and enrollment criteria are met.
Allocation
Randomized
Enrollment
279 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Roll-in Cohort
Arm Type
Other
Arm Description
Each Investigator will be allowed to treat up to 3 roll-in subjects with the Spring Implant prior to initiation of randomization. Roll-in patients will be followed for 60 months.
Arm Title
Treatment Arm
Arm Type
Active Comparator
Arm Description
Includes all patients who are randomized and start the treatment procedure. During the procedure the patient will be shielded from the treatment area and cystoscopy screen. The patient and site personnel administering follow-up assessments will be blinded to the study arm through the 3-month follow-up visit. Unblinding will occur at 3 months post-procedure after the assessments are completed. Follow up will continue for 60 months.
Arm Title
Control Arm
Arm Type
Sham Comparator
Arm Description
Includes all patients who receive a sham procedure. Patients will be shielded from the treatment area and cystoscopy screen. A Foley Catheter is placed into the patient's bladder and inflated. Additionally, devices will be used to produce mock deployment sounds of the Zenflow procedure. Once complete, the balloon will be deflated and the catheter will be removed, completing the procedure. Control arm subjects are followed for 3 months and exited from the study unless they elect and qualify for Crossover.
Arm Title
Crossover Cohort
Arm Type
Other
Arm Description
Control Arm (Sham) patients can receive treatment with the Zenflow Spring System after their 3-month follow-up assessments are completed, and their symptoms warrant treatment and enrollment criteria are met. The study visit follow-up schedule will restart and the subject will be followed for 60 months post Zenflow Spring implantation. Unless treated with the Spring System, the subject will be exited from the study once they have completed their 3-month follow-up visit.
Intervention Type
Device
Intervention Name(s)
Zenflow Spring System
Intervention Description
The Zenflow Spring Implant is an electropolished and passivated nickel titanium alloy (nitinol) implant. The implant is constructed from a single wire strand formed into ring elements connected by spine sections. There are four sizes of implants ranging from 16 mm to 24 mm in length and 14 mm to 16 mm in diameter to implant in the subject's prostatic urethra. The implant is placed in the urethra using a custom delivery catheter and cystoscope (Spring Scope). The implant is intended to be permanent but can be removed if necessary.
Intervention Type
Device
Intervention Name(s)
Sham Procedure
Other Intervention Name(s)
Foley Catheter
Intervention Description
A18 Fr Foley Catheter is placed into the patient's bladder. To mimic the Treatment Arm procedure, the Foley Catheter balloon will be inflated in the bladder. Once inflated, slight tension will be applied against the subject's bladder neck. While tension is being applied the site staff will follow a script to simulate the Zenflow procedural steps. Additionally, devices will be used to produce mock deployment sounds of the Zenflow procedure. Once complete, the balloon will be deflated and the catheter will be removed, completing the procedure.
Primary Outcome Measure Information:
Title
Safety - The need for urinary catheterization
Description
The rate of extended post-operative urinary catheterization (> 7 days from treatment) for inability to void among patients treated with the Zenflow Spring System.
Time Frame
Greater than 7 days after procedure
Title
Safety - Adverse Events
Description
The rate of device or procedure related serious adverse events in both the Treatment Arm and the Sham Arm.
Time Frame
Procedure through 12 months
Title
Effectiveness of the Spring Implant in reducing symptoms of Benign Prostatic Hyperplasia (BPH) as compared to Sham
Description
The Treatment Arm will be considered superior to the Control Arm (Sham) when the mean 3-month improvement from baseline score for the IPSS symptom questionnaire demonstrates a minimum statistical margin of 25% compared to mean improvement from baseline for the Control Arm (Sham) alone.
Time Frame
Procedure to 3 months
Title
Effectiveness- Symptoms Improvement
Description
The mean percent change in IPSS in the treatment arm is at least 30% improvement over the Patient's pre-treatment baseline score.
Time Frame
Procedure to 12 months
Secondary Outcome Measure Information:
Title
Safety - Adverse Events
Description
Rate of device or procedure related adverse events at all time points.
Time Frame
Procedure through 60 months
Title
Safety - Pain Assessment Questionnaire
Description
Comparison of pain at discharge to 2-week, 1- and, 3-month follow-up visits per Visual Analogue Scale (VAS) questionnaire. The VAS questionnaire asks the patient to indicate on a scale of 1 to 10 his level of pain where 1 is no pain and 10 is the worst pain.
Time Frame
Procedure through 3 months
Title
Safety - Sexual Health Questionnaire 1
Description
Change in sexual health characterized by the questionnaire Sexual Health Inventory for Men (SHIM).
Time Frame
3 months post procedure through 24 months post procedure
Title
Safety - Sexual Health Questionnaire 2
Description
Change in sexual health characterized by questionnaire Male Sexual Health Questionnaire - Ejaculatory Domain (MSHQ-EjD)
Time Frame
3 months post procedure through 24 months post procedure
Title
Safety - Device Removal
Description
Assessment of adverse events outcomes related to a Spring Implant removal procedure.
Time Frame
Procedure through 60 months
Title
Safety - Classification of Adverse Events
Description
Proportion of patients with adverse events classified as Clavien-Dindo Grade IIIb or higher or any event resulting in persistent disability
Time Frame
Procedure through 3 months
Title
Effectiveness - long term symptom improvement 1
Description
Percent of patients who experience at least a 30 percent improvement in IPSS from their baseline pre-treatment score
Time Frame
Procedure through 12 months
Title
Effectiveness - long term symptom improvement 2
Description
Mean percent change in IPSS in the treatment arm compared to baseline at all timepoints other than the primary endpoints.
Time Frame
Procedure through 60 months
Title
Effectiveness - flow metrics
Description
Change from baseline in uroflowmetry measures of peak flow rate (Qmax)
Time Frame
1 month post procedure through 60 months
Title
Effectiveness - Re-intervention (device)
Description
Post-procedure incidence of secondary reintervention using an alternate surgical LUTS therapy.
Time Frame
Procedure through 60 months
Title
Effectiveness - Re-intervention (drug)
Description
Post-procedure incidence of secondary reintervention using standard pharmacological agents for LUTS therapy.
Time Frame
Procedure through 60 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject is able and willing to comply with all the assessments of the study, Subject or subject's legal representative has been informed of the nature of the study, agrees to participate and has signed the informed consent form, ≥ 45 years of age, Baseline IPSS score ≥ 13; ≥ 1 in the IPSS voiding to storage sub-score ratio (IPSS-V/S), Prostate volume 25 - 80 cc by transrectal ultrasound (TRUS), measured within 120 days post study consent, Prostatic urethral length between 25 and 45 mm, as measured by cystoscopic pull-back, Failed, intolerant, or subject choice to not take a medication regimen for the treatment of LUTS. Exclusion Criteria: Obstructive intravesical median prostatic lobe as determined by ultrasound (i.e., more than 10 mm intravesical prostatic protrusion on sagittal mid-prostate plane via abdominal ultrasound), High bladder neck with the absence of lateral lobe encroachment indicating a high likelihood of primary bladder neck obstruction as determined by the Investigator, Urethral stricture, meatal stenosis, or bladder neck stricture - either current or recurrent, Anatomical anomalies that will not accommodate the Implant, as determined by cystoscopy (e.g., prostatic urethral length to height geometry), Requires indwelling catheter or intermittent catheterization to void, Baseline PSA > 10 ng/mL or confirmed or suspected prostate cancer (Subjects with a PSA level above 2.5 ng/mL, or age specific, or local reference ranges should have prostate cancer excluded to the Investigator's satisfaction), One of the following baseline test results, taken from a single uroflowmetry reading: Urinary volume void ≤ 125mL (pre-bladder urinary volume of ≥ 150 mL required), Peak urinary flow rate (Qmax) of ≤ 5 ml/second or > 15 mL/second, Post- void residual volume (PVR) > 250 mL History of other diseases causing voiding dysfunction including urinary retention (e.g., uncontrolled diabetes, diagnosis of neurogenic bladder, Parkinson's disease, multiple sclerosis, etc.), Subjects with overactive bladder in the absence of benign prostatic obstruction, Acute urinary tract infection (UTI) or finding of asymptomatic bacteriuria (Note: subject can be enrolled if the UTI is treated and followed with a negative urine test result), or subjects with history of recurrent UTIs (defined as > 3 UTIs in the past 12 months), Concomitant bladder stones, Previous pelvic irradiation or radical pelvic surgery, Previous prostate surgery, including: enucleation, resection, vaporization, thermotherapy, ablation, stenting or prostatic urethral lift, Chronic prostatitis, recurrent prostatitis, chronic pelvic pain syndrome (CPPS), or painful bladder syndrome within the past 12 months Known allergy to nickel, Life expectancy less than 60 months, Use of concomitant medications (e.g., anticholinergics, antispasmodics or tricyclic antidepressants) affecting bladder function, 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 (Note: low dose aspirin therapy (81 mg) is permitted), Taking 5-alpha-reductase inhibitors within 3 months of baseline evaluation, Taking one of the following within 2 weeks of baseline evaluation: alpha-blockers, imipramine, anticholinergics, cholinergic gonadotropin releasing hormonal analogues, Phosphodiesterase-5 Enzyme Inhibitors (Tadalafil) in doses for BPH, Beta-3 adrenergic receptor agonist (Mirabegron), Taking androgens, unless eugonadal state for at least 3 months or greater as documented by the Investigator, Taking one of the following within 24 hours of pre-treatment (baseline) evaluation: phenylephrine, or, pseudoephedrine, Future fertility concerns, or, In the Investigator's opinion, the subject has a physical, psychological, or medical impairment that might prevent study completion or would confound study results (including subject questionnaires).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fudda Ababseh
Phone
6504197557
Email
fuddaababseh@zenflow.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claus Roehrborn, M.D
Organizational Affiliation
UT Southwestern, Dallas, TX
Official's Role
Principal Investigator
Facility Information:
Facility Name
American Institute of Research
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Northshore University Health System
City
Glenview
State/Province
Illinois
ZIP/Postal Code
60026
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Helfand, MD
Phone
847-503-3000
First Name & Middle Initial & Last Name & Degree
Pooja Talaty
Phone
847-503-3000
Facility Name
Sheldon Freedman, MD, LTD
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89144
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Carolina Urologic Research Associates
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neal Shore, MD
Phone
843-839-1679
First Name & Middle Initial & Last Name & Degree
Crystal Mitchell
Phone
(843) 839-1679
Facility Name
Midtown Urology Associates
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Trotter, MD
Phone
512-451-7935
First Name & Middle Initial & Last Name & Degree
Andrew P Barger, MSN
Phone
(512) 451-7935
Facility Name
Urology Austin, PLLC
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Mazzarella, MD
Phone
512-443-5988
First Name & Middle Initial & Last Name & Degree
Pankti Bhatia
Phone
(512) 443-5988
Facility Name
Urology of Virginia, PLLC
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23462
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gregg Eure, MD
Phone
757-457-5100
First Name & Middle Initial & Last Name & Degree
Sabrina Delfenthal
Phone
757-457-5100

12. IPD Sharing Statement

Plan to Share IPD
No

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Safety and Effectiveness Study of the Zenflow Spring System

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