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Transrectal Ultrasound Robot-Assisted Prostate Biopsy

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02871726
Recruitment Status : Recruiting
First Posted : August 18, 2016
Last Update Posted : October 15, 2019
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE August 10, 2016
First Posted Date  ICMJE August 18, 2016
Last Update Posted Date October 15, 2019
Study Start Date  ICMJE January 2016
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 15, 2016)
  • Number of patients with treatment-related adverse events [ Time Frame: 1.5 years ]
    The PI will contact each participant approximately one week after their biopsy to ask if they have experienced any adverse events due to the study device. If all 5 participants complete the procedure and fail to report any adverse events, the device will be considered safe for use during biopsy.
  • Number of patients for whom the study-related procedures can be completed in less than 30 minutes [ Time Frame: 1.5 years ]
    The amount of time to complete the study-related portion of the biopsy will be noted. If the study-study portion of the biopsy is able to be completed in less than 30 minutes for each of the 5 participants, then the device will be considered feasible for use during biopsy.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Transrectal Ultrasound Robot-Assisted Prostate Biopsy
Official Title  ICMJE Transrectal Ultrasound Robot-Assisted Prostate Biopsy
Brief Summary The commonly used diagnostic procedure for prostate cancer, a transrectal ultrasound (TRUS)-guided biopsy, has significant limitations. Freehand biopsy cores are often spatially clustered, rather than uniformly distributed, and do not accurately follow the recommended, sextant template. In addition, a freehand TRUS-guided biopsy does not allow precise mapping of the biopsy cores within the prostate. Therefore, it is nearly impossible to re-biopsy or target the exact cancer foci. As a result, most TRUS-guided prostate biopsies today are poorly targeted and their spatial mapping remains subjective.
Detailed Description This proposed feasibility and safety study of 5 patients attempts to improve TRUS-guided prostate biopsy by utilizing a novel robotic TRUS manipulator (TRUS Robot). A successful TRUS Robot guidance will provide crucial spatial information of the biopsy cores for improved prostate cancer detection, treatment, and monitoring. This proposed study is a proof of concept for a future protocol.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Prostate Cancer
Intervention  ICMJE Device: TRUS-Robot
A robotic device used to hold and manipulate the ultrasound probe during a transrectal prostate biopsy
Study Arms  ICMJE Experimental: Experimental
TRUS and TRUS-Robot will be used during prostate biopsy
Intervention: Device: TRUS-Robot
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 12, 2017)
100
Original Estimated Enrollment  ICMJE
 (submitted: August 15, 2016)
5
Estimated Study Completion Date  ICMJE August 2020
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Scheduled for an initial diagnostic biopsy
  • Elevated serum PSA (prostate specific antigen> 4 ng/ml) and/or abnormal digital rectal exam

Exclusion Criteria:

  • Clinical diagnosis of prostate cancer
  • Prior prostate biopsy
  • Anal stenosis that prevents TRUS probe insertion
  • Inadequate bowel prep
  • Unwilling or unable to sign the informed consent
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 40 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Misop Han, M.D., M.S. 410-614-9442 mhan1@jhmi.edu
Contact: Vince Torres, B.A. 410-502-5938 vtorres7@jhmi.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02871726
Other Study ID Numbers  ICMJE IRB00068488
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Misop Han, M.D., M.S. Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP