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

Aperture Medical Technology

Status: Enrolling

Conditions: Hematologic Malignancy

Treatments: Device: Portomar(TM) Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT05583734

Study Number: 1339403

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

Portomar(TM) Device

Experimental group

Description:

Portomar(TM) Device for bone marrow biopsy Subjects are self-controlled with one side having conventional biopsy and the other having the Portomar(TM) biopsy.

Treatment:

Device: Portomar(TM) Device