Butterfly Pivotal Study

NCT05341661 | Active Not Recruiting FDA Device

• 1 other identifier: CL-BM14-001
• Study Type: interventional
• Target: 245
• Locations: 1 country
• Sites: 3

Brief Summary

A prospective, multicenter, blind randomized (2:1) controlled study comparing the International Prostate Symptom Score (IPSS) of the Active arm to the IPSS of the control arm at the 3 months follow-up and active arm IPSS score change from time zero to 12 months. Patients in the active arm undergo Butterfly device treatment. Patients in the control arm undergo a sham rigid cystoscopy procedure

Conditions

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

Keywords

BPH, LUTS

Outcome Measures

Primary Outcomes (2)

• Change from baseline to month 3 in International Prostate Symptom Score (IPSS) Score.

  Analysis will compare the active and control study arms IPSS

  3 month

• Change in active arm International Prostate Symptom Score (IPSS) from baseline to 12 months

  Analysis will assess the IPSS percent change for the active arm compared to a baseline score

  12 month

Study Arms (3)

Active

ACTIVE COMPARATOR

The active arm patients undergo the Butterfly device procedure.

Device: Butterfly Prostatic Retraction Device

Sham Comparator

SHAM COMPARATOR

The sham control arm patients undergo a rigid cystoscopy procedure.

Device: Butterfly Prostatic Retraction Device

Cross over

OTHER

Sham arm patient is allowed to crossover and undergo the Butterfly procedure

Device: Butterfly Prostatic Retraction Device

Interventions

Butterfly Prostatic Retraction Device DEVICE

Implantation of the Butterfly device

Active; Cross over; Sham Comparator

Eligibility Criteria

• Age: 50 Years - 120 Years
• Gender Eligibility Details: Male age 50 years old and up, suffering from LUTS due to BPH
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male patient age 50 and up
• Willing and able to sign informed consent
• Willing and able to comply with all study assessments
• Prostate length of 25mm-45mm (from apex of the prostate to the beginning of the bladder neck).
• Prostate volume 30-90 ml
• Symptomatic BPH: IPSS ≥ 13; ≥ 1 in the IPSS voiding to sub-score ratio (IPSS-V/S)

You may not qualify if:

• Known sensitivity to Nickel.
• Current urinary retention
• Urinary stress incontinence (sphincter)
• Biopsy of the prostate within the last 6 weeks
• Baseline PSA \> 10 ng/mL or confirmed or suspected prostate cancer. Patients with a PSA level above 2.5 ng/mL, in which free PSA is \< 25% of total PSA in whom cancer was not ruled out by biopsy.
• Chronic prostatitis, recurrent prostatitis, chronic pelvic pain syndrome (CPPS), or painful bladder syndrome within the past 12 months
• Obstructing intraprostatic median lobe (e.g., more than 10mm intravesical prostatic protrusion).
• Urethral stricture, meatal stenosis, or bladder neck stricture - either current or recurrent.
• Anatomical anomalies that will not accommodate the retractor, as determined by cystoscopy (e.g., prostatic urethral length to height geometry, absence of bladder neck)
• Prior surgery or minimal invasive procedure of prostate (brachytherapy and PAE patients are not excluded if they show significant obstruction in urodynamic test and cystoscopy shows no significant fibrosis).
• Currently active bladder tumor or intravesical instillation.
• History of other diseases causing voiding dysfunction including urinary retention (e.g., uncontrolled diabetes, diagnosis of neurogenic or atonic bladder, Parkinson's disease, multiple sclerosis, etc.).
• Suspected Neurogenic or atonic urinary bladder.
• Suspected Polyuria/Nocturnal Polyuria.
• Suspected overactive bladder

Sponsors & Collaborators

• Butterfly Medical Ltd.: lead

Study Sites (3)

Manhattan Medical Research

New York, New York, 10016, United States

Location

Northwell Health

Syosset, New York, 11791, United States

Location

Houston Methodist

Houston, Texas, 77030, 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

• Adrian Paz, MD

  Medical director

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: April 22, 2022
• Study Start: April 7, 2022
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2029
• Last Updated: January 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)