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Ultrasound Based Transperineal Robotic Biopsy of the the Prostate (BxB)

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.
ClinicalTrials.gov Identifier: NCT01102361
Recruitment Status : Unknown
Verified May 2006 by Singapore General Hospital.
Recruitment status was:  Recruiting
First Posted : April 13, 2010
Last Update Posted : April 13, 2010
Sponsor:
Information provided by:
Singapore General Hospital

Brief 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

Condition or disease Intervention/treatment Phase
Previous Negative Biopsy Procedure: Robotic Transperineal Biopsy Phase 1 Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Study of Prostate Cancer Detection With in House Developed Robot
Study Start Date : May 2006
Estimated Primary Completion Date : January 2011
Estimated Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Transperineal Biopsy
Biopsy of the prostate using transperineal approach
Procedure: Robotic Transperineal Biopsy
Saturation biopsy for previous negative patients



Primary Outcome Measures :
  1. Cancer Detection [ Time Frame: 2 years ]
    to detect any undetected cancer in Patietns undergoing saturation biopsy


Secondary Outcome Measures :
  1. Accuracy and Repeatability [ Time Frame: 6 months ]
    To be accurate in biopsy position (+/- 2mm) and be able to go back to the same position if patient undergoes treatment.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • At least one normal previous prostate biopsy and at least 2 weeks since prior prostate biopsy
  • Increasing prostate-specific antigen (PSA) level
  • The Investigator has completed a medical history and a physical examination to assure that the subjects meet all study enrollment criteria

Exclusion Criteria:

  • Patient with operative risk ASA ( American Society of Anaesthesia) = or > 4
  • A history of bleeding disorders/coagulopathy or ongoing treatment for this condition
  • Patients with psychiatric diseases or insufficient cerebral function

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): NCT01102361


Contacts
Contact: Henry Ho, Doctor ho.henry.s.s@gmail.com
Contact: Preeti Mohan, Biomedical Engineer preeti.mohan@gmail.com

Locations
Singapore
Singapore General Hospital Recruiting
Singapore, Singapore, 169608
Contact: Henry Ho, Doctor       ho.henry.s.s@gmail.com   
Contact: Preeti Mohan       preeti.mohan@gmail.com   
Principal Investigator: Christoper Cheng         
Sub-Investigator: Henry Ho         
Sub-Investigator: John Yuen         
Sponsors and Collaborators
Singapore General Hospital

Responsible Party: Prof. Chris Cheng, Singapore General Hospital
ClinicalTrials.gov Identifier: NCT01102361     History of Changes
Other Study ID Numbers: BioXbot
First Posted: April 13, 2010    Key Record Dates
Last Update Posted: April 13, 2010
Last Verified: May 2006