Ultrasound Based Transperineal Robotic Biopsy of the the Prostate
NCT01102361 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 250
Last updated 2010-04-13
Summary
The objective of the study is to examine the effectiveness and accuracy of the BioXbot in prostate biopsy as opposed to transrectal biopsy. This evaluation of the efficacy of both the procedures is based on:
* Uptake rate
* Peripheral zone reachability
* Needling accuracy
* Procedure execution time
* Post operative discomfort or trauma experienced by patient
* Quality and type of tissue sample extracted
* Adverse and unanticipated side-effects on patient after the procedure and recording any unexpected reactions
Conditions
- Previous Negative Biopsy
Interventions
- PROCEDURE
-
Robotic Transperineal Biopsy
Saturation biopsy for previous negative patients
Sponsors & Collaborators
-
Singapore General Hospital
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2006-05-31
- Primary Completion
- 2011-01-31
- Completion
- 2011-06-30
Countries
- Singapore
Study Locations
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