Prospective, Multi-Center Study of the ClariCore Optical Biopsy System in Patients Undergoing Transperineal Prostate Biopsy for Prostate Tissue Classification Algorithm Development
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Correlation of histopathology of tissue with ultrasound images and spectral data
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
ClariCore System
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.
干预措施: ClariCore System (Device)
结局指标
主要结局
Correlation of histopathology of tissue with ultrasound images and spectral data
时间窗: 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.
次要结局
- Incidence of Adverse Events (Safety)(At time of procedure)