Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT05341661
NA

Butterfly Pivotal Study

Sponsor: Butterfly Medical Ltd.

View on ClinicalTrials.gov

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

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

Key Details

Gender

MALE

Age Range

50 Years - 120 Years

Study Type

INTERVENTIONAL

Enrollment

245

Start Date

2022-04-07

Completion Date

2029-12-31

Last Updated

2025-01-15

Healthy Volunteers

No

Interventions

DEVICE

Butterfly Prostatic Retraction Device

Implantation of the Butterfly device

Locations (3)

Manhattan Medical Research

New York, New York, United States

Northwell Health

Syosset, New York, United States

Houston Methodist

Houston, Texas, United States