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3D Recording of a Trans-rectal Prostate Biopsy

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2011 by HaEmek Medical Center, Israel.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01314456
First Posted: March 14, 2011
Last Update Posted: March 16, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Bnai Zion Medical Center
Barzilai Medical Center
Meir Medical Center
Information provided by:
HaEmek Medical Center, Israel
  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
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 3D Recording of a Trans-rectal Prostate Biopsy

Resource links provided by NLM:


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 ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: March 11, 2011
First Posted: March 14, 2011
Last Update Posted: March 16, 2011
Last Verified: March 2011

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

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