Prostate CancerNCT03734575
ClariCore System Used in Transperineal Prostate Biopsy
A study testing ClariCore System in people with Prostate Cancer, run by Precision Biopsy, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- ClariCore System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Oct 2018to 9 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The James Buchanan Brady Urological Institute and Department of Urology
Baltimore, Maryland, 21287
NYU Langone Urology Associates
New York, New York, 10016
About this study
Official title: Prospective, Multi-Center Study of the ClariCore Optical Biopsy System in Patients Undergoing Transperineal Prostate Biopsy for Prostate Tissue Classification Algorithm Development
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- ClariCore System
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClariCore SystemDevice
The user will perform a standard trans-perineal biopsy and collect a number of biopsy cores as per standard practice.
| Study group | Role | What they receive |
|---|---|---|
| ClariCore System | Experimental | 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. Receives: Device: ClariCore System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At time of procedure
Secondary outcomes (1)
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.
Measured: At time of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study start10 Oct 2018
- Primary completion9 Jul 2019
- Study completion9 Jul 2019 (estimated)
Why it stopped: Company funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Precision Biopsy, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James Wysock, MD, Principal investigator, NYU Langone Urology Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03734575
- Sponsor's protocol ID
- CIP-1012
- Status last verified
- Jul 2019
- First submitted
- 16 Oct 2018
- Last updated
- 11 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multi-Center Study of the ClariCore Optical Biopsy System in Patients Undergoing Transperineal Prostate Biopsy for Prostate Tissue Classification Algorithm Development
- ClinicalTrials.gov ID
- NCT03734575
- Acronym / sponsor ID
- CIP-1012
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Company funding
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Precision Biopsy, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- 9 Jul 2019 (actual)
- Study completion
- 9 Jul 2019 (estimated)
- First posted
- 8 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ClariCore System | Experimental | Device: ClariCore SystemBiopsy 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. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ClariCore SystemThe user will perform a standard trans-perineal biopsy and collect a number of biopsy cores as per standard practice. | Device | ClariCore System |
Primary outcome
Correlation of histopathology of tissue with ultrasound images and spectral data
Time frame: At time of procedure
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.
1 secondary outcome
Incidence of Adverse Events (Safety)
Time frame: At time of procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Wysock, MD principal investigator
NYU Langone Urology Associates
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ClariCore System in people with Prostate Cancer, run by Precision Biopsy, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 11 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of histopathology of tissue with ultrasound images and spectral data (time frame: At time of procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2019.