ClariCore System Used in Transrectal Ultrasound Guided Prostate Biopsy for Real-Time Tissue Evaluation
NCT ID: NCT03504761
Last Updated: 2019-02-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
325 participants
INTERVENTIONAL
2018-04-25
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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ClariCore System
ClariCore System study designed to obtain prostate biopsies utilizing real-time tissue classification with the ClariCore Optical Biopsy System.
ClariCore Optical Biopsy System
Demonstrate the efficacy and safety of the ClariCore System in obtaining prostate biopsies utilizing real-time tissue classification.
Interventions
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ClariCore Optical Biopsy System
Demonstrate the efficacy and safety of the ClariCore System in obtaining prostate biopsies utilizing real-time tissue classification.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient scheduled for TRUS-guided prostate biopsy based on standard of care urologic requirements to assess for tissue malignancy (abnormal Digital Rectum Examination, Prostate Specific Antigen kinetics, age, ethnicity, family history, etc.)
* Enrolling physician must have expectation that prostate dimensions will meet minimum prostate volume and height requirements that will be evaluated at start of biopsy procedure (i.e., Prostate volume \> 20cc and height at least 22mm)
* Patient signs an Institutional Review Board approved, Informed Consent form to participate in the study prior to any study mandated determinations or procedure
Exclusion Criteria
* Acute painful perianal disorder (i.e. rectal abscess)
* Symptomatic, acute prostatitis
* Surgical absence of a rectum or the presence of a rectal fistula
* Patient has systemic infection or evidence of any surgical site infection (superficial or organ space), including active urinary tract infection
* Previous prostate intervention \[Transurethral Prostatectomy (TURP) (bipolar, monopolar, laser)\], Transurethral Microwave Thermotherapy (TUMT), High-Intensity Focused Ultrasound (HIFU), Cryo, Rezum, Urolift\], not including previous prostate biopsy
* Current use of blood thinning agents for medical comorbidity which prohibits the cessation of use as typically required per standard of care (SOC) or history of a bleeding disorder (e.g. coagulopathy)
* Prior pelvic irradiation
* Actively receiving therapy for the treatment of cancer (except for patients on 5-alpha reductase inhibitors, or non-melanoma skin cancers that are managed nonsystemically)
* Actively receiving intravesical therapy or within 6 months of treatment for bladder cancer
* Patient has compromised immune system
* Active inflammatory bowel disease within the last 6 months
* Any condition, or history of illness or surgery that, in the opinion of the Investigator, might confound the results of the study or pose additional risks to the patient (e.g. significant cardiovascular conditions or allergies)
* Patient is not likely to comply with the protocol or follow up evaluation
* Patient is participating in a clinical trial of another investigational drug or device that may impact participation in this clinical study
* Patient is unable to provide legal Informed Consent
22 Years
MALE
No
Sponsors
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Precision Biopsy, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Neal Shore, M.D.
Role: PRINCIPAL_INVESTIGATOR
Carolina Urologic Research Center/Atlantic Urology Clinics
Locations
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The Urology Center of Colorado
Denver, Colorado, United States
Brady Urological Institute, Johns Hopkins Hospital
Baltimore, Maryland, United States
NYU Langone Urology Associates
New York, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
Urology of San Antonio
San Antonio, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Robin Dorsey
Role: primary
Other Identifiers
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CIP-1010-B
Identifier Type: -
Identifier Source: org_study_id
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