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

Last updated: April 21, 2024
Sponsor: Aperture Medical Technology, LLC
Overall Status: Active - Recruiting

Phase

N/A

Condition

Blood Cancer

Hematologic Neoplasms

Treatment

Portomar(TM) Device

Clinical Study ID

NCT05583734
Study Number: 1339403
  • Ages > 21
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • • Patients with a previous bone marrow disorder diagnosis who will require multiplebone marrow biopsies over the course of their treatment, for example patients withplasma 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 (patientsnot on dialysis), or hepatic (patients with bilirubin below 2.5) function statussuitable to undergo port implantation and subsequent bone marrow biopsies.
  • Patients must be able to understand and be willing to sign a voluntary informedconsent form and agree to compliance with the protocol schedule; with theknowledge that they may withdraw consent at any time without impact on futuremedical care.

Exclusion

Exclusion Criteria:

  • • Patients with any other ongoing, concomitant, comorbid illness including but notlimited to uncontrolled diabetes, NYHA class III or worse heart failure, uncontrolledcoronary artery disease/arrhythmia.
  • Patients unable to comply with the study schema.
  • Confirmed pregnancy at time of screening or on implantation day prior toanesthesia/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 atthe target site of implantation. This is based on the patient's prior imagingstudies (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 studybiopsy.
  • 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 schizophreniaor major depression defined by the DSM-V criteria.
  • Patients with osteoporosis defined as L1 vertebrae bone density lower than 90Hounsfield units

Study Design

Total Participants: 32
Treatment Group(s): 1
Primary Treatment: Portomar(TM) Device
Phase:
Study Start date:
November 22, 2022
Estimated Completion Date:
October 31, 2025

Study Description

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.

Connect with a study center

  • MD Anderson

    Houston, Texas 77030
    United States

    Active - Recruiting

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