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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

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Device: TRUS-Robot Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Transrectal Ultrasound Robot-Assisted Prostate Biopsy
Study Start Date : January 2016
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy Ultrasound

Arm Intervention/treatment
Experimental: Experimental
TRUS and TRUS-Robot will be used during prostate biopsy
Device: TRUS-Robot
A robotic device used to hold and manipulate the ultrasound probe during a transrectal prostate biopsy




Primary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02871726


Contacts
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Contact: Misop Han, M.D., M.S. 410-614-9442 mhan1@jhmi.edu
Contact: Vince Torres, B.A. 410-502-5938 vtorres7@jhmi.edu

Locations
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United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Misop Han, M.D.    410-614-9442      
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Misop Han, M.D., M.S. Johns Hopkins University

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02871726    
Other Study ID Numbers: IRB00068488
First Posted: August 18, 2016    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Johns Hopkins University:
Prostate Cancer Detection
Prostate Biopsy
Prostate Cancer
Transrectal Ultrasound
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases