Safety and Effectiveness Study of the Zenflow Spring System

NCT04987138 | Active Not Recruiting DMC FDA Device

• 1 other identifier: CLIN-0130
• Study Type: interventional
• Target: 279
• Locations: 1 country
• Sites: 7

Brief Summary

Evaluate the safety and effectiveness of the Zenflow Spring System in relieving LUTS associated with BPH.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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.

  Greater than 7 days after procedure

• Safety - Adverse Events

  The rate of device or procedure related serious adverse events in both the Treatment Arm and the Sham Arm.

  Procedure through 12 months

• 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.

  Procedure to 3 months

• 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.

  Procedure to 12 months

Secondary Outcomes (11)

• Safety - Adverse Events

  Procedure through 60 months

• Safety - Pain Assessment Questionnaire

  Procedure through 3 months

• Safety - Sexual Health Questionnaire 1

  3 months post procedure through 24 months post procedure

• Safety - Sexual Health Questionnaire 2

  3 months post procedure through 24 months post procedure

• Safety - Device Removal

  Procedure through 60 months

Study Arms (4)

Roll-in Cohort

OTHER

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.

Device: Zenflow Spring System

Treatment Arm

ACTIVE COMPARATOR

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.

Device: Zenflow Spring System

Control Arm

SHAM COMPARATOR

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.

Device: Sham Procedure

Crossover Cohort

OTHER

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.

Device: Zenflow Spring System

Interventions

Zenflow Spring System DEVICE

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.

Crossover Cohort; Roll-in Cohort; Treatment Arm

Sham Procedure DEVICE

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.

Also known as: Foley Catheter

Control Arm

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Zenflow, Inc.: lead

Study Sites (7)

American Institute of Research

Los Angeles, California, 90017, United States

Location

Northshore University Health System

Glenview, Illinois, 60026, United States

Location

Sheldon Freedman, MD, LTD

Las Vegas, Nevada, 89144, United States

Location

Carolina Urologic Research Associates

Myrtle Beach, South Carolina, 29572, United States

Location

Midtown Urology Associates

Austin, Texas, 78705, United States

Location

Urology Austin, PLLC

Austin, Texas, 78745, United States

Location

Urology of Virginia, PLLC

Virginia Beach, Virginia, 23462, United States

Location

MeSH Terms

Conditions

Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Claus Roehrborn, M.D

  UT Southwestern, Dallas, TX

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: August 3, 2021
• Study Start: September 30, 2021
• Primary Completion: June 30, 2024
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 11, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)