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The Zenflow Spring System Safety, Performance and Effectiveness Study (ZEST2)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03595735
Recruitment Status : Recruiting
First Posted : July 23, 2018
Last Update Posted : October 29, 2019
Sponsor:
Information provided by (Responsible Party):
Zenflow, Inc.

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).

Condition or disease Intervention/treatment Phase
Benign Prostatic Hyperplasia Device: Zenflow Spring System Not Applicable

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 (24 months).

Whether or not the study continues to Stage 2, all enrolled subjects will be followed for the entire duration of the study (24 months), or until exited.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Multi-center, prospective, single-arm.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Zenflow Spring System Safety, Performance and Effectiveness Study (ZEST2)
Actual Study Start Date : June 21, 2018
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : March 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment Group
Receives treatment with the Zenflow Spring System
Device: Zenflow Spring System
The Zenflow Spring System consists of the Spring Delivery System with Implant, Spring Scope, Camera Control Unit (CCU), Measurement Tool, and Spring Retrieval Tool.
Other Name: Spring Implant




Primary Outcome Measures :
  1. Successful placement of the Zenflow Spring Implant [ Time Frame: Day of discharge up to 7 days following device placement ]
    Successful deployment and procedural success for the Zenflow System to implant the Spring device in the operating room or an out-patient clinical setting.

  2. Need for urinary catheterization [ Time Frame: 7 days after the procedure ]
    Rate of extended post-operative urinary catheterization


Secondary Outcome Measures :
  1. Incidence of procedure or device related serious adverse events [ Time Frame: Day of discharge up to 7 days following device placement ]
    Assessment of any device or procedure related Serious Adverse Events (SAE)

  2. Assessment of Pain [ Time Frame: Baseline, 2 weeks, 1 month and 3 months ]
    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.

  3. Assessment of Adverse Events [ Time Frame: Up to 2 years ]
    Rate of adverse events related to the procedure or device.

  4. Assessment of Sexual Health: Change in sexual health measured by change in the Sexual Health Inventory for Men (SHIM) questionnaire score [ Time Frame: Baseline, 3, 6, 12, & 24 months ]
    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.

  5. 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) [ Time Frame: Baseline, 3, 6, 12, & 24 months ]
    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.

  6. 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). [ Time Frame: Baseline, 2 weeks, 1, 6, 12, 24 months ]
    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.

  7. Effectiveness of the Spring Implant in reducing symptoms of Benign Prostatic Hyperplasia (BPH) [ Time Frame: Baseline, 2 weeks, 1, 3, 6, 12, 24 months ]
    Improvement in flow of urine

  8. Repeat interventions to treat Benign Prostatic Hyperplasia (BPH) [ Time Frame: Up to 2 years ]
    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.

  9. Increase or change in medications to treat Benign Prostatic Hyperplasia (BPH) [ Time Frame: Up to 2 years ]
    Incidence of increase in dosage, or initiation of new medication to treat symptoms of BPH.



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

All subjects are required to meet the following inclusion criteria in order to be considered eligible for participation in this trial:

  1. ≥ 45 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 and prostatic urethral length between 2.5-4.5 cm.
  4. 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:

  1. Obstructive intravesical 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. Baseline PSA > 10 ng/mL or confirmed or suspected prostate cancer
  4. Elevated risk of prostate cancer
  5. Post-void residual volume (PVR) > 250 ml
  6. Peak urinary flow rate > 12 ml/second, with ≥ 125 ml voided volume at baseline
  7. History of chronic urinary retention
  8. History of neurogenic bladder
  9. Compromised renal function (e.g., serum creatinine > 1.8 mg/dl) due to bladder obstruction
  10. Concomitant Urinary Tract Infection (UTI) (subject can be enrolled following successful treatment of UTI and a clean urine test)
  11. Concomitant bladder stones
  12. Confirmed or suspected bladder cancer
  13. Previous pelvic irradiation or radical pelvic surgery
  14. Previous prostate surgery, stent implantations, laser prostatectomy, hyperthermia or another invasive treatment to the prostate
  15. Chronic prostatitis, or recurring prostatitis within the past 12 months
  16. Serious concurrent medical conditions such as uncontrolled diabetes
  17. Known allergy to nickel
  18. Life expectancy less than 24 months
  19. Use of concomitant medications (e.g., anticholinergics, antispasmodics or antidepressants) affecting bladder function
  20. 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
  21. 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)
  22. 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)
  23. Future fertility concerns
  24. Any severe illness that might prevent study completion or would confound study results

Information from the National Library of Medicine

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): NCT03595735


Contacts
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Contact: Debra Cogan, B.A., R.N. +001 408 515-0820 dmcogan@gmail.com
Contact: Nicholas Damiano, MS +001 650 642-9658 Nick@zenflow.com

Locations
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Mexico
Hospital Regional de Alta Especialidad de Ixtapaluca Not yet recruiting
Zoquiapan, Ciudad de Ixtapaluca, Mexico, 56530
Contact: Rodrigo Becerra Perez, MD    + (52 55) 5972 9800    becerra151@yahoo.com.mx   
Contact: Melanie Racette, RN    5215528551962    mel_r999@hotmail.com   
Hospital Universitario "Dr. José Eleuterio González" Recruiting
Monterrey, Nuevo León, Mexico, 64460
Contact: Lauro Gomez, MD    +(52 81) 8333 1713 ext 3136    laurogomez@hotmail.com   
Centro de Urología Avanzada del Noreste (CUAN) Recruiting
Monterrey, Nuevo León, Mexico, 66269
Contact: Juan J Galan, MD    +(52 81) 8363 1717    maraboto@cuancima.com.mx   
Contact: Antonia Salazar, RN    +(52 81) 8363 1717    antoniasalazar@cuancima.com.mx   
Sponsors and Collaborators
Zenflow, Inc.
Investigators
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Principal Investigator: Juan J Galan, MD Centro de Urología Avanzada del Noreste (CUAN)
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Responsible Party: Zenflow, Inc.
ClinicalTrials.gov Identifier: NCT03595735    
Other Study ID Numbers: CLIN-0043
First Posted: July 23, 2018    Key Record Dates
Last Update Posted: October 29, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Hyperplasia
Pathologic Processes
Prostatic Diseases