ClariCore System Used in Transrectal Ultrasound Guided Prostate Biopsy for Real-Time Tissue Evaluation

Status unconfirmed · Not applicable

Conditions studied: Cellular Diagnosis, Prostate Cancer

In brief

The purpose of this study is to demonstrate the effectiveness and safety of the ClariCore System in obtaining prostate biopsies with device feedback that provides real-time tissue classification.

Key facts

Study ID

NCT03504761

Run by

Precision Biopsy, Inc.

People needed

325

Starts

2018-04-25

Expected to finish

2020-12-01

Last updated by the study team

2019-02-15

Who can join

Age: 22 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Males > 22 years old
• 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

You may not qualify if…

• Any anatomical or co-morbidity contraindications to TRUS prostate biopsy
• 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

Where it is running

• The Urology Center of Colorado — Denver, Colorado, United States (enrolling)
• NYU Langone Urology Associates — New York, New York, United States (enrolling)
• Carolina Urologic Research Center — Myrtle Beach, South Carolina, United States (enrolling)
• Brady Urological Institute, Johns Hopkins Hospital — Baltimore, Maryland, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• Urology of San Antonio — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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