A Prospective Study of Conventional Bone Marrow Biopsies and Bone Marrow Biopsies Performed Through the Portomar(TM), Using a Modified PROMIS Pain Intensity Scale for Pain Assessment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Pain intensity
研究概览
简要总结
This is a self-controlled, prospective trial. The objective of this trial is to evaluate the efficacy and safety of the Portomar(TM) device for bone marrow biopsy.
详细描述
This is a self-controlled, prospective trial. Subjects will undergo conventional bone marrow biopsy compared to bone marrow biopsy with the Portomar(TM) device. Subjects will be evaluated at multiple time points comparing the two biopsies. Data through the 6 month time point will be used for Regulatory Submission to the FDA. Additionally subjects will be followed for two years post enrollment.
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
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Patients with a previous bone marrow disorder diagnosis who will require multiple bone marrow biopsies over the course of their treatment, for example patients with plasma cell dyscrasia or leukemia.
- •Men and non-pregnant women of age ≥ 21 years with ECOG performance status ≤
- •Any hematologic (platelets above 50, ANC > 1.0, hemoglobin > 7), renal (patients not on dialysis), or hepatic (patients with bilirubin below 2.5) function status suitable to undergo port implantation and subsequent bone marrow biopsies.
- •Patients must be able to understand and be willing to sign a voluntary informed consent form and agree to compliance with the protocol schedule; with the knowledge that they may withdraw consent at any time without impact on future medical care.
排除标准
- •• Patients with any other ongoing, concomitant, comorbid illness including but not limited to uncontrolled diabetes, NYHA class III or worse heart failure, uncontrolled coronary artery disease/arrhythmia.
- •Patients unable to comply with the study schema.
- •Confirmed pregnancy at time of screening or on implantation day prior to anesthesia/sedation.
- •Patients unable to come off of anticoagulation medications for their procedure.
- •Patients with active infection.
- •Patients with < 0.5 cm or > 2.5 cm of soft tissue between screw head and skin at the target site of implantation. This is based on the patient's prior imaging studies (i.e. CT/MR or ultrasound imaging).
- •Patient has contra-indication to conscious sedation or anesthesia services
- •Patients who have had prior bone marrow biopsy within 2 weeks of the study biopsy.
- •Patients with coagulopathy such that INR cannot be corrected < 2.
- •Patients who are prisoners or wards of the court.
- •Patients with alcohol or substance abuse disorder defined by DSM V criteria.
- •Patients with the diagnosis of a major psychiatric disorder such as schizophrenia or major depression defined by the DSM-V criteria.
- •Patients with osteoporosis defined as L1 vertebrae bone density lower than 90 Hounsfield units
结局指标
主要结局
Pain intensity
时间窗: Day of bone marrow biopsy (approximately 1 month after Portomar(TM) placement)
Pain Comparison- The scale used to assess pain is a modified National Cancer Institute (NCI) Patient Reported Outcome Measurement Information System (PROMIS). Patients are asked to rate their pain intensity from 0 (no pain)-10 (worst pain ever) comparing the bone marrow biopsy performed with the Portomar(TM) device and a standard bone marrow biopsy. The endpoint will be the proportion of patients experiencing at least a 2 point improvement in score between Portomar(TM) and standard biopsy.
Portomar(TM) pain intensity
时间窗: 90 days after study begins with Portomar(TM) placement
Pain related to Portomar(TM) will be assessed using the same modified NCI PROMIS
次要结局
- Safety Events(Study duration, approximately 2 years)
- Specimen-Core Biopsy(Study duration (approximately 2 years) at all bone marrow biopsied performed with Portomar(TM))
- Time(Study duration (approximately 2 years) at all bone marrow biopsied performed with Portomar(TM))
- Satisfaction Score(Day of placement and every time a bone marrow biopsy is performed using the Portomar(TM) device for study duration approximately 2 years)
- Pain Score(Study duration (approximately 2 years) at all bone marrow biopsies with Portomar(TM))
- Specimen-Aspirate(Study duration (approximately 2 years) at all bone marrow biopsied performed with Portomar(TM))