A Prospective Study of Conventional Bone Marrow Biopsy Versus Portomar(TM) Biopsy

Summary

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.

Eligibility

Inclusion Criteria:

* • 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 ≤ 2.
  * 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.

Exclusion Criteria:

* • 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 \< 2.0.
  * 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

Conditions2

Locations1 site

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