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

Description

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.

Conditions

Hematologic Malignancy

Study Overview

Study Details

Study overview

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.

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

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

Condition
Hematologic Malignancy
Intervention / Treatment

-

Contacts and Locations

Houston

MD Anderson, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * • 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

Ages Eligible for Study

21 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Aperture Medical Technology, LLC,

Rahul Sheth, PRINCIPAL_INVESTIGATOR, MD Anderson

Study Record Dates

2025-10