3D Recording of a Trans-rectal Prostate Biopsy
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Create 3D model of the prostate and accurately display the locations of the various biopsies taken during the procedure
Study Overview
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.
Detailed Description
3D record of a trans-rectal prostate biopsy
Clinical Study Protocol Study no: NaviGo -01
Sponsor: UC-CARE. Apollo Bld. 3rd fl. Hi-Tech Park P.O.Box 67 Yokneam 20692 Israel Tel: 972-4-9097427 Fax:972-4-9937323
Feb. 2011 Version: 02
ABBREVIATIONS:
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: NaviGo (Device)
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported