NCT03595735

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 21, 2018

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

July 12, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 23, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2024

Completed
Last Updated

July 22, 2021

Status Verified

July 1, 2021

Enrollment Period

2.5 years

First QC Date

July 12, 2018

Last Update Submit

July 15, 2021

Conditions

Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (2)

  • Successful placement of the Zenflow Spring Implant

    Successful deployment and procedural success for the Zenflow System to implant the Spring device in the operating room or an out-patient clinical setting.

    Day of discharge up to 7 days following device placement

  • Need for urinary catheterization

    Rate of extended post-operative urinary catheterization

    7 days after the procedure

Secondary Outcomes (9)

  • Incidence of procedure or device related serious adverse events

    Day of discharge up to 7 days following device placement

  • Assessment of Pain

    Baseline, 2 weeks, 1 month and 3 months

  • Assessment of Adverse Events

    Up to 2 years

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

    Baseline, 3, 6, 12, & 24 months

  • 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)

    Baseline, 3, 6, 12, & 24 months

  • +4 more secondary outcomes

Study Arms (1)

Treatment Group

EXPERIMENTAL

Receives treatment with the Zenflow Spring System

Device: Zenflow Spring System

Interventions

Zenflow Spring SystemDEVICE

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

Also known as: Spring Implant
Treatment Group

Eligibility Criteria

Age45 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 45 years of age
  • Baseline IPSS score \> 13, and a baseline Quality of Life (QoL) question score \> 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.
  • Failed or intolerant to medication regimen for the treatment of LUTS.

You may not qualify if:

  • Subjects will be excluded from participating in this trial if they meet any of the following criteria:
  • Obstructive intravesical median prostatic lobe or high bladder neck
  • Urethral stricture, meatal stenosis, or bladder neck obstruction - either current, or recurrent requiring 2 or more dilatations
  • Baseline PSA \> 10 ng/mL or confirmed or suspected prostate cancer
  • Elevated risk of prostate cancer
  • Post-void residual volume (PVR) \> 250 ml
  • Peak urinary flow rate \> 12 ml/second, with ≥ 125 ml voided volume at baseline
  • History of chronic urinary retention
  • History of neurogenic bladder
  • Compromised renal function (e.g., serum creatinine \> 1.8 mg/dl) due to bladder obstruction
  • Concomitant Urinary Tract Infection (UTI) (subject can be enrolled following successful treatment of UTI and a clean urine test)
  • Concomitant bladder stones
  • Confirmed or suspected bladder cancer
  • Previous pelvic irradiation or radical pelvic surgery
  • Previous prostate surgery, stent implantations, laser prostatectomy, hyperthermia or another invasive treatment to the prostate
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hospital Regional de Alta Especialidad de Ixtapaluca

Zoquiapan, Ciudad de Ixtapaluca, 56530, Mexico

Location

Hospital Universitario "Dr. José Eleuterio González"

Monterrey, Nuevo León, 64460, Mexico

Location

Centro de Urología Avanzada del Noreste (CUAN)

Monterrey, Nuevo León, 66269, Mexico

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Juan J Galan, MD

    Centro de Urología Avanzada del Noreste (CUAN)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Multi-center, prospective, single-arm.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2018

First Posted

July 23, 2018

Study Start

June 21, 2018

Primary Completion

December 30, 2020

Study Completion

March 30, 2024

Last Updated

July 22, 2021

Record last verified: 2021-07

Locations

ME(3)