RecruitingNot ApplicableNCT05583734
A Prospective Study of Conventional Bone Marrow Biopsy Versus Portomar(TM) 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
Sponsor
Aperture Medical Technology, LLC
Enrollment
32 participants
Start Date
Nov 22, 2022
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 21 Years
Inclusion Criteria4
- 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 Criteria13
- 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
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Interventions
DEVICEPortomar(TM) Device
Portomar(TM) access device for bone marrow biopsy
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05583734
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