3D Recording of a Trans-rectal Prostate Biopsy

Summary

Prostate biopsy is performed by multiple consecutive biopsy needle insertion into the prostate gland under a trans-rectal ultrasound probe guidance.

Today, the performing physician navigates the needle using a momentary 2D ultrasound image (longitudinal and transverse B mode) without any record of the full prostate boundaries or previous biopsies' location.

This study's Objectives are to record the trans-rectal biopsy procedure including the initial scan and the needle biopsy location and to modulate a 3D model of the prostate with accurate display the locations of the various biopsies taken during the procedure.

Conditions

• Prostate Cancer
• Benign Prostatic Hyperplasia

Interventions

DEVICE

NaviGo

Video recording of a normal TRUS guided prostate biopsy with additional 2 , non invasive,electromagnetic sensors attached to the TRUS probe and the patient's back,- to allow for a 3D modeling of the prostate.

Sponsors & Collaborators

• Bnai Zion Medical Center

  collaborator OTHER_GOV

• Barzilai Medical Center

  collaborator OTHER

• Meir Medical Center

  collaborator OTHER

• HaEmek Medical Center, Israel

  lead OTHER

Principal Investigators

• Boris Yudkevich, MD · HaEmek Medical Center, Israel

• Genady Zelichenko, MD · HaEmek Medical Center, Israel

• Ilan Leibovich, MD · Meir Medical center, Israel

• Giora Tikotchinsky, MD · Meir medical center, Israel

• Moshe Shalev, MD · Meir medical center, Israel

• Ofer Nativ, Prof., MD · Bnei-Zion medical center, Israel

• Shmuel Cytron, MD · Barzilai medical center, Israel

• Michael Cohen, MD · HaEmek Medical Center, Israel

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-03-31

Primary Completion

2011-12-31

Completion

2011-12-31

Countries

• Israel

Study Locations