MedTrace Logo

Butterfly Pivotal Study

NCT05341661 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 245

Last updated 2025-01-15

No results posted yet for this study

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

DEVICE

Butterfly Prostatic Retraction Device

Implantation of the Butterfly device

Sponsors & Collaborators

  • Butterfly Medical Ltd.

    lead INDUSTRY

Principal Investigators

  • Adrian Paz, MD · Medical director

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
120 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-07
Primary Completion
2025-12-31
Completion
2029-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05341661 on ClinicalTrials.gov