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3D Recording of a Trans-rectal Prostate Biopsy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by HaEmek Medical Center, Israel.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
Bnai Zion Medical Center
Barzilai Medical Center
Meir Medical Center
Information provided by:
HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT01314456
First received: March 11, 2011
Last updated: March 14, 2011
Last verified: March 2011
History of Changes
  Purpose

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.


Condition Intervention
Prostate Cancer
Benign Prostatic Hyperplasia
 Device: NaviGo

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 3D Recording of a Trans-rectal Prostate Biopsy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by HaEmek Medical Center, Israel:

Primary Outcome Measures:
  • Create 3D model of the prostate and accurately display the locations of the various biopsies taken during the procedure [ Time Frame: Post procedure ( off-line ) within a 3-5 working days ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: March 2011
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
 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.
Other Name: 3D recording of a trans-rectal prostate biopsy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patient's unwilling to participate
  • Patients with metal prosthetics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01314456

Contacts
Contact: Michael mo Cohen, MD +972-544-764444 dr.m.cohen@gmail.com

Locations
Israel
Dept. of urology , HaEmek medical center Not yet recruiting
Afula, Israel
Sponsors and Collaborators
HaEmek Medical Center, Israel
Bnai Zion Medical Center
Barzilai Medical Center
Meir Medical Center
Investigators
Study Director: Boris Yudkevich, MD HaEmek Medical Center, Israel
Study Director: Genady Zelichenko, MD HaEmek Medical Center, Israel
Principal Investigator: Ilan Leibovich, MD Meir Medical center, Israel
Study Director: Giora Tikotchinsky, MD Meir medical center, Israel
Study Director: Moshe Shalev, MD Meir medical center, Israel
Principal Investigator: 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
  More Information

No publications provided

Responsible Party: Michael Cohen, MD, Urology, HaEmek Medical center
ClinicalTrials.gov Identifier: NCT01314456     History of Changes
Other Study ID Numbers: NaviGo- 01, 3D TRUS Bx recording
Study First Received: March 11, 2011
Last Updated: March 14, 2011
Health Authority: Israel: Ethics Commission

Keywords provided by HaEmek Medical Center, Israel:
Prostate biopsy
Trans-rectal ultrasound
Prostate cancer

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Prostatic Neoplasms
Prostatic Diseases
Genital Diseases, Male
 Pathologic Processes
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on May 19, 2013