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A Novel 3D Navigation Technology for Improved TRUS Prostate Biopsy (NaSBxP01)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by UC Care, Ltd.
Sponsor:
Information provided by (Responsible Party):
UC Care, Ltd.
ClinicalTrials.gov Identifier:
NCT01480375
First received: November 23, 2011
Last updated: January 15, 2013
Last verified: January 2013
  Purpose

Prostate biopsy is a procedure in which small samples are removed from a man's prostate gland to be later tested for the presence of cancer. It is typically performed when the scores from a PSA blood test rise to a level that is associated with the possible presence of prostate cancer.

The most common method for performing a prostate biopsy procedure is the ultrasound guided transrectal procedure. The information obtained from the standard prostate biopsy is deficient and even misleading. Cancers can be missed on initial and even in repeated biopsy. Moreover, the detection of a tumor cannot predict accurately the tumor size and location1. It was proven that the exact location of the obtained cores, even in an initial biopsy, can influence the cancer detection rate2.

An imaging tool that will enable a three-dimensional navigation in the prostate volume and selecting biopsy locations in view of previous core taken will allow building a "tumor map" '(i.e. detecting tumor size and location). By mapping the prostate cancer an adequate treatment can be chosen while avoiding over or insufficient treatment.

However, to be able to produce an accurate mapping of the malignant tissue, a complementary optimized pathology method should be also implement in addition to the navigation system, it has been shown that a pre-embedding procedure that keeps the specimen orientation, unfolding, unity, and location along the needle notch improves the histological yield and hence the cancer detection rate3.

The NaviGo™ Workstation (hereafter the NaviGo™ Workstation or the NaviGo™ System) allows physicians to see the prostate gland together with the biopsy sites in a three dimensional (3D) view, modeled from two dimensional (2D) images. The NaviGo™ Workstation was designed as an adjunct to standard of care procedures, to work with standard rectal ultrasound probes, and to be incorporated side by side with the techniques currently employed. No change to the current employed procedures and techniques is required or suggested. In complementary to the Navigo system a system for semi-automatic download of prostate biopsy cores which keeps the orientation, unfolding and unity of the sample was developed to increase the pathology utility.

The study objective is to evaluate the contribution of the Navigo™ system, an aiding navigation tool for TRUS prostate biopsy, to an increase in the prostate cancer detection ability.


Condition Intervention
Prostate Cancer
Device: Navigo system

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: A 3D Navigation Technology for Improved TRUS Prostate Biopsy

Resource links provided by NLM:


Further study details as provided by UC Care, Ltd.:

Primary Outcome Measures:
  • increased prostate cancer detection rate [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    prostate cancer detection rate would be compared to that of a retrospetive cohort of patients who underwent prostate biopsy without the Navigo device.


Estimated Enrollment: 150
Study Start Date: September 2011
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: prostate biopsy using the Navigo system.
Evaluate the contribution of the Navigo™ system, an aiding navigation tool for TRUS prostate biopsy, to increase the prostate cancer detection ability.
Device: Navigo system

The NaviGo workstation is used as an adjunct to the ultrasound imaging and biopsy procedures of the prostate gland. When operated in conjunction with the standard equipment in a TRUS guided prostate biopsy procedure, the NaviGo™ software may be used for the following:

  • To assist the physician by transfer and display of ultrasound images on the workstation screen;
  • Build display and manipulate a 3D model of the prostate on screen;
  • Archiving the ultrasound images and the 3D model;
  • Providing data management solutions;
  • Tracking, displaying and recording of the biopsy needle trajectory location in real time.

  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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01480375

Contacts
Contact: Ofer Nativ, Prof. 972-48359523

Locations
Israel
Bnai Zion medical center Recruiting
Haifa, Israel, 31048
Contact: Ofer Nativ, Prof.    972-4-8359523      
Sponsors and Collaborators
UC Care, Ltd.
Investigators
Principal Investigator: Ofer Nativ, Prof. Bnai Zion Medical Center
  More Information

No publications provided

Responsible Party: UC Care, Ltd.
ClinicalTrials.gov Identifier: NCT01480375     History of Changes
Other Study ID Numbers: 0053-11-BNZ
Study First Received: November 23, 2011
Last Updated: January 15, 2013
Health Authority: Israel: Ethics Commission

Keywords provided by UC Care, Ltd.:
prostate cancer detection
prostate biopsy
3d navigation
trans rectal ultrasound

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

ClinicalTrials.gov processed this record on November 27, 2014