NCT03912558

Brief Summary

This study evaluates the safety and efficacy of use of the Butterfly Medical's prostatic retraction device in Benign Prostatic Hyperplasia (BPH) Patients. The study follows patients implanted with the Butterfly device for up to 1 year after implantation. Evaluations include recording of safety events and BPH related symptoms by Uroflowmetry tests and International Prostate Symptom Score (IPSS) questionnaires. The study also assess sexual quality of life after implantation of the Butterfly device.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

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

October 29, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 11, 2019

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

August 6, 2024

Status Verified

August 1, 2024

Enrollment Period

5.4 years

First QC Date

April 7, 2019

Last Update Submit

August 5, 2024

Conditions

BPHBOO - Bladder Outflow Obstruction

Keywords

BPHBOOEnlarged prostateLUTSUrinary obstructionRetrograde ejaculation

Outcome Measures

Primary Outcomes (5)

  • Reported device related adverse events

    Assess the rate, nature and severity of device-related adverse events reported

    12 months post procedure

  • Cystoscopic assessment - inflammation

    Cystoscopic assessment to evaluate lack of local inflammation

    12 months post procedure

  • Cystoscopic assessment - incrustations

    Cystoscopic assessment to evaluate no incrustations

    12 months post procedure

  • Cystoscopic assessment - implant coverage

    Cystoscopic assessment to evaluate coverage by mucosa

    12 months post procedure

  • Device migration

    Rate of migration of the Butterfly device

    12 months post procedure

Secondary Outcomes (4)

  • Symptoms reduction - IPSS

    Baseline to 12 months post procedure

  • Symptoms reduction - Qmax

    Baseline to 12 months post procedure

  • Sexual quality of life evaluation - erectile dysfunction

    12 month post procedure

  • Sexual quality of life evaluation - retrograde ejaculation

    12 month post procedure

Study Arms (1)

Butterfly device implantation

EXPERIMENTAL

Butterfly device implantation will be performed following initial cystoscopy to evaluate prostate condition and rule out other pathologies. Following implant size selection, the Butterfly implant will be deployed and positioned through the cystoscope over-sheath. After deployment the cystoscope (with its optics) will be re-introduced into the urethra to examine the Butterfly device position.

Procedure: Butterfly device implantation

Interventions

Butterfly device implantationPROCEDURE

The Butterfly device will be positioned and deployed with cystoscopy guidance

Butterfly device implantation

Eligibility Criteria

Age50 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 50 or older
  • Verified BPH with prostate size of at least 30 grams or of 25 mm.
  • Signed Informed Consent
  • Failure, intolerance or patient non-compliance of medical treatment
  • Patients suffering from LUTS symptoms of BPH (IPSS \>12, Qmax=\<13 ml/sec)
  • Patient's voided volume of at least 125 ml in uroflow test
  • Patients not eligible for surgery or refusing surgery

You may not qualify if:

  • Known sensitivity to Nickel
  • Active Prostatitis
  • Urethral strictures
  • Prior surgery of prostate (simple or radical)
  • Currently active bladder tumor
  • Suspected neurogenic urinary bladder
  • Suspected a-contractile bladder
  • Enlarged median lobe of prostate.
  • Bladder Neck stricture or contracture
  • Urethral pathology: diverticula, strictures, tumors, fistula
  • Clinically Significant urinary tract infection
  • Uncontrolled bleeding disorders
  • Uncontrolled diabetes mellitus
  • Severe medical diseases precluding a minimally invasive procedure
  • Present active urinary stone disease
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Shamir Medical Center

Be’er Ya‘aqov, Israel

Location

Bnei Zion

Haifa, Israel

Location

Rabin Medical Center

Petah Tikva, Israel

Location

Ziv Medical Center

Safed, Israel

Location

MeSH Terms

Conditions

Retrograde Ejaculation

Condition Hierarchy (Ancestors)

Ejaculatory DysfunctionGenital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital Diseases

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

April 7, 2019

First Posted

April 11, 2019

Study Start

October 29, 2018

Primary Completion

April 1, 2024

Study Completion

April 1, 2024

Last Updated

August 6, 2024

Record last verified: 2024-08

Locations

IL(4)