NCT01314456

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable prostate-cancer

Timeline
Completed

Started Mar 2011

Shorter than P25 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 14, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

March 16, 2011

Status Verified

March 1, 2011

Enrollment Period

9 months

First QC Date

March 11, 2011

Last Update Submit

March 14, 2011

Conditions

Prostate CancerBenign Prostatic Hyperplasia

Keywords

Prostate biopsyTrans-rectal ultrasoundProstate cancer

Outcome Measures

Primary Outcomes (1)

  • Create 3D model of the prostate and accurately display the locations of the various biopsies taken during the procedure

    Post procedure ( off-line ) within a 3-5 working days

Study Arms (1)

NaviGo

EXPERIMENTAL

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.

Device: NaviGo

Interventions

NaviGoDEVICE

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.

Also known as: 3D recording of a trans-rectal prostate biopsy
NaviGo

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years or older
  • Planned for trans-rectal prostate biopsy
  • Signed informed consent

You may not qualify if:

  • Patient's unwilling to participate
  • Patients with metal prosthetics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of urology , HaEmek medical center

Afula, Israel

Location

MeSH Terms

Conditions

Prostatic NeoplasmsProstatic Hyperplasia

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Boris Yudkevich, MD

    HaEmek Medical Center, Israel

    STUDY DIRECTOR

  • Genady Zelichenko, MD

    HaEmek Medical Center, Israel

    STUDY DIRECTOR

  • Ilan Leibovich, MD

    Meir Medical center, Israel

    PRINCIPAL INVESTIGATOR

  • Giora Tikotchinsky, MD

    Meir medical center, Israel

    STUDY DIRECTOR

  • Moshe Shalev, MD

    Meir medical center, Israel

    STUDY DIRECTOR

  • Ofer Nativ, Prof., MD

    Bnei-Zion medical center, Israel

    PRINCIPAL INVESTIGATOR

  • Shmuel Cytron, MD

    Barzilai medical center, Israel

    PRINCIPAL INVESTIGATOR

  • Michael Cohen, MD

    HaEmek Medical Center, Israel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael mo Cohen, MD

CONTACT

+972-544-764444dr.m.cohen@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 11, 2011

First Posted

March 14, 2011

Study Start

March 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

March 16, 2011

Record last verified: 2011-03

Locations

IL(1)