The Zenflow Spring System Safety and Performance Study (ZEST CAN)

NCT04309695 | Unknown DMC

• 1 other identifier: CLIN-0111
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

The objectives of the trial are to demonstrate the safety and performance of the Zenflow Spring System in relieving the symptoms of obstructive Benign Prostatic Hyperplasia (BPH).

Conditions

Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (4)

• Successful placement of the Zenflow Spring Implant

  Number of successful deployments and procedural successes for the Zenflow System to implant the Spring device in the OR, or in an out-patient clinical setting as compared to total treatment attempts.

  Day of discharge up to 7 days following device placement

• Effectiveness of the Spring Implant in reducing symptoms of Benign Prostatic Hyperplasia (BPH) using the International Prostate Symptom Score

  At 3 months, achieve at least 30% mean improvement in International Prostate Symptom Score (IPSS) compared to baseline. The patient is asked to respond to 7 questions related to his urinary health using a rating scale of 0 to 5 where zero is excellent and 5 is the worst possible. The responses to the 7 questions are tallied for a total IPSS score.

  3 month

• Need for urinary catheterization

  Achieve \< 12% rate of extended post-operative urinary catheterization, defined as an occurrence of a subject requiring catheterization within the first 3 days as part of a postoperative management for inability to void, for greater than 7 days.

  7 days after the procedure

• Incidence of procedure or device related serious adverse events

  Achieve \< 12% rate of device or procedure related SAEs through discharge and 30 days follow up.

  30 days after the procedure

Secondary Outcomes (9)

• Assessment of Sexual Health Assessment: Change in sexual health measured by change in the Sexual Health Inventory for Men (SHIM) questionnaire score

  Baseline, 3, 6, 12, 24, 36, 48, & 60 months

• Assessment of Pain, evaluated using a Visual Analog Score (VAS) of 1 to 10

  Baseline, interoperative (if conscious sedation used), immediately post-treatment, 2 weeks, 1 and 3 months

• Assessment of Adverse Events

  Up to 5 years

• Assessment of Clavien-Dindo events

  Up to 5 years

• Assessment of PSA

  Up to 5 years

Study Arms (1)

Treatment Group

EXPERIMENTAL

Receives intervention with the Zenflow Spring System.

Device: Zenflow Spring System

Interventions

Zenflow Spring System DEVICE

The Zenflow Spring is a nitinol urethral implant for the treatment of Lower Urinary Tract Symptoms (LUTS) that arise due to bladder outlet obstruction (BOO), secondary to the presence of Benign Prostatic Hypertrophy (BPH). The device is intended to be a permanent implant however it may be removed if necessary.

Treatment Group

Eligibility Criteria

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

You may qualify if:

• Patient is able and willing to comply with all the assessments of the study
• Patient or patient'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
• Prostate volume 25 - 80 cc and prostatic urethral length between 2.5-4.5 cm measured within the past 90 days
• Failed, intolerant, or patient choice to not take a medication regimen for the treatment of LUTS

You may not qualify if:

• Obstructive intravesical median prostatic lobe which in the opinion of the operator would not benefit from treatment
• Urethral stricture, meatal stenosis, or bladder neck obstruction - either current, or recurrent requiring 2 or more dilations as reported in the patient's history
• Requiring self-catheterization to void.
• Baseline PSA \> 10 ng/mL or confirmed or suspected prostate cancer
• Any of the following, taken from a single uroflowmetry reading:
• Post-void residual volume (PVR) \> 250 ml
• Peak urinary flow rate of \> 15 ml/second
• \< 125 ml urinary volume voided at baseline (pre-bladder urinary volume of ≥150 ml required)
• Other condition or disease that might cause urinary retention
• History of other diseases causing voiding dysfunction
• Concomitant Urinary Tract Infection (UTI) (subject can be enrolled following successful treatment of UTI and a clean urine test), or subjects who have a history of recurrent or chronic UTIs (defined as 2 or more UTIs in the past 12 months)
• Concomitant bladder stones
• 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

Sponsors & Collaborators

• Zenflow, Inc.: lead

Study Sites (2)

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

RECRUITING

Groupe Sante Brunswick

Pointe-Claire, Quebec, H9R 5K3, Canada

RECRUITING

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Emily Hu

CONTACT

5109098237; emily@zenflow.com

Kevin MacDonald

CONTACT

415-609-9875; kfmacdonald@zenflow.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2020
• First Posted: March 16, 2020
• Study Start: February 9, 2021
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: July 19, 2021

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)