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Trial Title:
A Prospective Study of Conventional Bone Marrow Biopsy Versus Portomar(TM) Biopsy
NCT ID:
NCT05583734
Condition:
Hematologic Malignancy
Conditions: Official terms:
Hematologic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Self-controlled, prospective trial
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Portomar(TM) Device
Description:
Portomar(TM) access device for bone marrow biopsy
Arm group label:
Portomar(TM) Device
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.
Detailed 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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
21 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
MD Anderson
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Rahul Sheth, MD
Phone:
713-745-4794
Start date:
November 22, 2022
Completion date:
October 2025
Lead sponsor:
Agency:
Aperture Medical Technology, LLC
Agency class:
Industry
Source:
Aperture Medical Technology, LLC
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05583734
