The Zenflow Spring System Safety, Performance and Effectiveness Study

NCT ID: NCT03595735

Last Updated: 2021-07-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-21
• Study Completion Date: 2024-03-30

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.

Conditions

Benign Prostatic Hyperplasia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Group

Receives treatment with the Zenflow Spring System

Group Type: EXPERIMENTAL

Zenflow Spring System

Intervention Type: DEVICE

The Zenflow Spring System consists of the Spring Delivery System with Implant, Spring Scope, Camera Control Unit (CCU), Measurement Tool, and Spring Retrieval Tool.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Spring Implant

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Zenflow, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Juan J Galan, MD

Role: PRINCIPAL_INVESTIGATOR

Centro de Urología Avanzada del Noreste (CUAN)

Locations

Hospital Regional de Alta Especialidad de Ixtapaluca

Zoquiapan, Ciudad de Ixtapaluca, Mexico

Hospital Universitario "Dr. José Eleuterio González"

Monterrey, Nuevo León, Mexico

Centro de Urología Avanzada del Noreste (CUAN)

Monterrey, Nuevo León, Mexico

Countries

Mexico

Other Identifiers

CLIN-0043

Identifier Type: -

Identifier Source: org_study_id