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
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
Connect with a study center
MD Anderson
Houston, Texas 77030
United StatesActive - Recruiting
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