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

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ClinicalTrials.gov Identifier: NCT01480375
Recruitment Status : Recruiting
First Posted : November 28, 2011
Last Update Posted : May 4, 2018
Sponsor:
Information provided by (Responsible Party):
UC Care, Ltd.

Brief Summary:

he 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 or disease Intervention/treatment Phase
Prostate Cancer Device: Smartbx™ system. Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A 3D Navigation Technology for Improved TRUS Prostate Biopsy
Study Start Date : September 2011
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Navigo™ and Smartbx™ system.
all biopsy cores were handled using the Smartbx™ system. part of the procedures were performed with both Navigo™ and Smartbx™ system.
Device: Smartbx™ system.
The SmartBx™ system semi-automated downloads the biopsy cores from the biopsy needle onto a designated cassette which integrates into the routine pathology lab processing. The core is downloaded in an oriented and straightened fashion while preserving core fragments in its original locations relative to the needle notch.
No Intervention: standard method
all biopsy cores were handled using standard method - shaking the biopsy needle into formalin vial. no navigation system.



Primary Outcome Measures :
  1. increased prostate cancer detection rate [ Time Frame: 30 days ]
    prostate cancer detection rate would be compared to that of a retrospetive cohort of patients who underwent prostate biopsy without the Navigo device.



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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

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): 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

Responsible Party: UC Care, Ltd.
ClinicalTrials.gov Identifier: NCT01480375     History of Changes
Other Study ID Numbers: 0053-11-BNZ
First Posted: November 28, 2011    Key Record Dates
Last Update Posted: May 4, 2018
Last Verified: May 2018

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

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