NCT05341661

Butterfly Pivotal Study

A Prospective, Randomized, Controlled, Blinded Study to Assess the Safety and Efficacy of the Butterfly Medical Prostatic Retraction Device in BPH Patients

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 245 (actual)
• Sponsor: Butterfly Medical Ltd. · Industry
• Sex: Male
• Age: 50 Years – 120 Years
• Healthy volunteers: Not accepted

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)

Interventions

Type	Name	Description
DEVICE	Butterfly Prostatic Retraction Device	Implantation of the Butterfly device

Timeline

• Start date: 2022-04-07
• Primary completion: 2025-12-31
• Completion: 2029-12-31
• First posted: 2022-04-22
• Last updated: 2025-01-15

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study