MedTrace Logo

Long Term Safety and Efficacy of Butterfly Medical Prostatic Retraction Device in Benign Prostatic Hyperplasia (BPH) Patients Who Completed 12 Months of Follow-Up Post Implantation (Continuation Study for Study BM-011-IL)

NCT05330520 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-08-08

No results posted yet for this study

Summary

This study evaluates the long term safety and efficacy of use of the Butterfly Medical's prostatic retraction device in Benign Prostatic Hyperplasia (BPH) Patients. The study follows patients implanted with the Butterfly device for up to 5 year after implantation.

The evaluations include recording of safety events and BPH related symptoms by Uroflowmetry tests, residual urine and International Prostate Symptom Score (IPSS) questionnaires. The study also assesses the sexual quality of life after implantation of the Butterfly device.

Conditions

  • BPH
  • BOO - Bladder Outflow Obstruction
  • Enlarged Prostate (BPH)

Interventions

PROCEDURE

Butterfly Medical Prostatic Retraction Device ("the Butterfly device") removal/replacement

when necessary, the device may be removed or replaced easily through the urethra due to its minimal surface and easy release from the mucosa covering it.

Sponsors & Collaborators

  • Butterfly Medical Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2021-02-10
Primary Completion
2027-02-01
Completion
2027-02-01

Countries

  • Israel

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 NCT05330520 on ClinicalTrials.gov