Comparing traditional bone marrow biopsy to 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
This study is testing a new device called Portomar(TM) to see if it makes bone marrow biopsies easier and safer for people with blood cancers compared to the traditional method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Aperture Medical Technology, LLC Industry-sponsored |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05583734 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the efficacy and safety of the Portomar(TM) device for bone marrow biopsy in patients with hematologic malignancies. Participants will undergo both conventional bone marrow biopsy and biopsy using the Portomar(TM) device, allowing for a direct comparison of the two methods. The study will assess outcomes at multiple time points, with data collected over a six-month period for regulatory submission to the FDA. Additionally, subjects will be monitored for two years post-enrollment to gather long-term safety and efficacy data.
Who should consider this trial
Good fit: Ideal candidates include adults aged 21 and older with a previous diagnosis of a bone marrow disorder requiring multiple biopsies.
Not a fit: Patients with uncontrolled comorbid conditions or those who do not require multiple bone marrow biopsies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective method for performing bone marrow biopsies in patients with blood cancers.
How similar studies have performed: While this approach is innovative, similar studies comparing biopsy techniques have shown promise in improving patient outcomes.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Houston, Texas
- MD Anderson — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Rahul Sheth — MD Anderson
- Study coordinator: S Solomon
- Email: info@aperturemed.com
- Phone: 6468663882
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.