Butterfly Pivotal Study

NCT ID: NCT05341661

Last Updated: 2025-01-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 245 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-07
• Study Completion Date: 2029-12-31

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Active

The active arm patients undergo the Butterfly device procedure.

Group Type: ACTIVE_COMPARATOR

Butterfly Prostatic Retraction Device

Intervention Type: DEVICE

Implantation of the Butterfly device

Sham Comparator

The sham control arm patients undergo a rigid cystoscopy procedure.

Group Type: SHAM_COMPARATOR

Butterfly Prostatic Retraction Device

Intervention Type: DEVICE

Implantation of the Butterfly device

Cross over

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

Group Type: OTHER

Butterfly Prostatic Retraction Device

Intervention Type: DEVICE

Implantation of the Butterfly device

Interventions

Butterfly Prostatic Retraction Device

Implantation of the Butterfly device

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Male patient age 50 and up

2. Willing and able to sign informed consent

3. Willing and able to comply with all study assessments

4. Prostate length of 25mm-45mm (from apex of the prostate to the beginning of the bladder neck).

5. Prostate volume 30-90 ml

6. Symptomatic BPH: IPSS ≥ 13; ≥ 1 in the IPSS voiding to sub-score ratio (IPSS-V/S)

Exclusion Criteria

1. Known sensitivity to Nickel.

2. Current urinary retention

3. Urinary stress incontinence (sphincter)

4. Biopsy of the prostate within the last 6 weeks

5. 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.

6. Chronic prostatitis, recurrent prostatitis, chronic pelvic pain syndrome (CPPS), or painful bladder syndrome within the past 12 months

7. Obstructing intraprostatic median lobe (e.g., more than 10mm intravesical prostatic protrusion).

8. Urethral stricture, meatal stenosis, or bladder neck stricture - either current or recurrent.

9. Anatomical anomalies that will not accommodate the retractor, as determined by cystoscopy (e.g., prostatic urethral length to height geometry, absence of bladder neck)

10. 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).

11. Currently active bladder tumor or intravesical instillation.

12. 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.).

13. Suspected Neurogenic or atonic urinary bladder.

14. Suspected Polyuria/Nocturnal Polyuria.

15. Suspected overactive bladder

16. High bladder neck with the absence of lateral lobe encroachment indicating a high likelihood of primary bladder neck obstruction as determined by the Investigator

17. Urethral pathology: diverticula, strictures, tumors, fistula.

18. Acute clinically Significant urinary tract infection.

19. Uncontrolled bleeding disorders.

20. Active stone disease (urinary stone increase in size during the last 3 months/ stone passage during the last 3 months/ presence of cystolithiasis)

21. Taking 5 alpha reductase inhibitors within 6 months of baseline evaluation

22. Taking one of the following within 2 weeks of baseline evaluation:

1. alpha-blockers,

2. imipramine,

3. anticholinergics,

4. Phosphodiesterase-5 Enzyme Inhibitors (Tadalafil) in doses for BPH,

5. Beta-3 adrenergic receptor agonist (Mirabegron),

23. Taking androgens, unless eugonadal state for at least 2 months or greater as documented by the Investigator

24. Taking Gonadotrophin releasing hormone analogues within 12 months of baseline evaluation

25. Taking one of the following within 24 hours of pre-treatment (baseline) evaluation:

phenylephrine, or, pseudoephedrine,

26. 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 and > 15 mL/second,
• Post- void residual volume (PVR) > 250 mL

27. Inmates, patient with physical, psychological (such as developmentally delayed adults), or medical impairment that might prevent study completion or would confound study results (including patient questionnaires) in the judgment of the Investigator

28. Currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Butterfly Medical Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adrian Paz, MD

Role: STUDY_DIRECTOR

Medical director

Locations

Manhattan Medical Research

New York, New York, United States

Northwell Health

Syosset, New York, United States

Houston Methodist

Houston, Texas, United States

Countries

United States

Other Identifiers

CL-BM14-001

Identifier Type: -

Identifier Source: org_study_id