Back to resultsClariCore System Used in Transperineal Prostate Biopsy
Primary Purpose
Prostate Cancer
Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ClariCore System
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
- Males per Investigator assessment appropriate for transperineal prostate biopsy
- Patient scheduled for transperineal prostate biopsy based on standard of care urologic requirements to assess for tissue malignancy
- Prostate volume > 20cc and length at least 22mm as verified by ultrasound or prostate MRI prior to the procedure
- Patient must be able to provide legal consent and signs an IRB (Institutional Review Board)/EC (Ethics Committee) approved Informed Consent form to participate in the study prior to any study mandated determinations or procedure
Exclusion Criteria:
- Any anatomical or co-morbidity contraindications to transperineal prostate biopsy or transperineal prostate mapping 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 [TURP (bipolar, monopolar, laser)] TUMT, HIFU, Cryo, Rezum, Urolift], not including previous prostate biopsy
- Current required use of blood thinning agents for medical comorbidity which prohibits the cessation of use as typically required per standard of care (SOC) prior to a medical procedure; 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, in the opinion of the Investigator
- 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
Sites / Locations
- The James Buchanan Brady Urological Institute and Department of Urology
- NYU Langone Urology Associates
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ClariCore System
Arm Description
Biopsy tissue, correlative spectral data, T2-weighted MR scans and ultrasound images acquired with the ClariCore System will be collected and recorded during standard practice transperineal biopsy.
Outcomes
Primary Outcome Measures
Correlation of histopathology of tissue with ultrasound images and spectral data
The correlation of histopathology of tissue biopsy core samples with the corresponding spectral data and ultrasound images obtained in vivo for the purpose of tissue classification algorithm development using a transperineal approach.
Secondary Outcome Measures
Incidence of Adverse Events (Safety)
The cumulative incidence of adverse events related to the device or the procedure. The cumulative incidence of serious adverse events (SAEs) related to the device or the procedure.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03734575
Brief Title
ClariCore System Used in Transperineal Prostate Biopsy
Official Title
Prospective, Multi-Center Study of the ClariCore Optical Biopsy System in Patients Undergoing Transperineal Prostate Biopsy for Prostate Tissue Classification Algorithm Development
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Suspended
Why Stopped
Company funding
Study Start Date
October 10, 2018 (Actual)
Primary Completion Date
July 9, 2019 (Actual)
Study Completion Date
July 9, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Precision Biopsy, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The overall objective of this study is to acquire ultrasound images, spectral data and prostate tissue biopsy cores using the ClariCore System via a transperineal approach.
Detailed Description
The overall objective of this study is to acquire ultrasound images, spectral data and prostate tissue biopsy cores using the ClariCore System via a transperineal approach. Ultrasound images corresponding to each needle insertion and T2-weighted MR scans will be saved for the purpose of further algorithm development that will provide physicians with real time tissue classification in conjunction with location information from the ultrasound imaging.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ClariCore System
Arm Type
Experimental
Arm Description
Biopsy tissue, correlative spectral data, T2-weighted MR scans and ultrasound images acquired with the ClariCore System will be collected and recorded during standard practice transperineal biopsy.
Intervention Type
Device
Intervention Name(s)
ClariCore System
Intervention Description
The user will perform a standard trans-perineal biopsy and collect a number of biopsy cores as per standard practice.
Primary Outcome Measure Information:
Title
Correlation of histopathology of tissue with ultrasound images and spectral data
Description
The correlation of histopathology of tissue biopsy core samples with the corresponding spectral data and ultrasound images obtained in vivo for the purpose of tissue classification algorithm development using a transperineal approach.
Time Frame
At time of procedure
Secondary Outcome Measure Information:
Title
Incidence of Adverse Events (Safety)
Description
The cumulative incidence of adverse events related to the device or the procedure. The cumulative incidence of serious adverse events (SAEs) related to the device or the procedure.
Time Frame
At time of procedure
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Males per Investigator assessment appropriate for transperineal prostate biopsy
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males per Investigator assessment appropriate for transperineal prostate biopsy
Patient scheduled for transperineal prostate biopsy based on standard of care urologic requirements to assess for tissue malignancy
Prostate volume > 20cc and length at least 22mm as verified by ultrasound or prostate MRI prior to the procedure
Patient must be able to provide legal consent and signs an IRB (Institutional Review Board)/EC (Ethics Committee) approved Informed Consent form to participate in the study prior to any study mandated determinations or procedure
Exclusion Criteria:
Any anatomical or co-morbidity contraindications to transperineal prostate biopsy or transperineal prostate mapping 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 [TURP (bipolar, monopolar, laser)] TUMT, HIFU, Cryo, Rezum, Urolift], not including previous prostate biopsy
Current required use of blood thinning agents for medical comorbidity which prohibits the cessation of use as typically required per standard of care (SOC) prior to a medical procedure; 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, in the opinion of the Investigator
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Wysock, MD
Organizational Affiliation
NYU Langone Urology Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
The James Buchanan Brady Urological Institute and Department of Urology
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
NYU Langone Urology Associates
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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ClariCore System Used in Transperineal Prostate Biopsy
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