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Portomar™ Device for Bone Marrow Biopsy Study

This study is looking at a new device called Portomar™ for bone marrow biopsies. Bone marrow biopsies are procedures where a small sample of bone marrow is taken, often to check on blood cancers (hematologic malignancies). The study wants to see if using the Portomar™ device is as good and safe as the usual way of doing bone marrow biopsies, especially regarding pain. You might be able to join if you are at least 21 years old, have a blood disorder that needs many bone marrow biopsies, and meet certain health requirements. The main goal is to compare the pain you feel with the Portomar™ device versus a standard biopsy. The study is currently unclear on its recruitment status and plans to enroll 32 participants.

Study design
This is a self-controlled study where participants will compare the Portomar™ device to conventional bone marrow biopsy. It is an interventional study with an unclear phase, planning to enroll 32 participants.
What's involved
Participants will undergo both conventional bone marrow biopsies and biopsies using the Portomar™ device. Pain intensity will be measured at the time of Portomar™ placement, one day after placement, and on the day of the bone marrow biopsy (about one month after Portomar™ placement).
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for two years after they join the study. Data through the 6-month mark will be used for regulatory submission.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05583734

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

UNKNOWN
NAAges 21+InterventionalDiagnostic
Aperture Medical Technology, LLC
~32 participants
Updated 2024-04-23 on ClinicalTrials.gov
What's tested:Portomar(TM) Device

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pain intensity
Measured over Day of bone marrow biopsy (approximately 1 month after Portomar(TM) placement)
+7 more outcomes measured

Conditions

Hematologic Malignancy

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Malignant neoplasm of lymphoid, hematopoietic and/or related tissue

NCT05583734

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • MD Anderson

    Houston, Texasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Rahul Sheth · PRINCIPAL_INVESTIGATOR · MD Anderson

Who to contact

S Solomon
[email protected]
6468663882
Email the study team

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Eligibility criteria

Inclusion

• 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

• 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

What this trial measures

  • Pain intensityDay of bone marrow biopsy (approximately 1 month after Portomar(TM) placement)

    Pain Comparison- The scale used to assess pain is a modified National Cancer Institute (NCI) Patient Reported Outcome Measurement Information System (PROMIS). Patients are asked to rate their pain intensity from 0 (no pain)-10 (worst pain ever) comparing the bone marrow biopsy performed with the Portomar(TM) device and a standard bone marrow biopsy. The endpoint will be the proportion of patients experiencing at least a 2 point improvement in score between Portomar(TM) and standard biopsy.

  • Portomar(TM) pain intensityDay of placement (beginning of study)

    Pain related to Portomar(TM) will be assessed using the same modified NCI PROMIS Scale. The endpoint is the proportion of patients experiencing severe pain (\>8).

  • Portomar(TM) pain intensity1 day after study begins with Portomar(TM) placement

    Pain related to Portomar(TM) will be assessed using the same modified NCI PROMIS

  • Portomar(TM) pain intensity2 days after study begins with Portomar(TM) placement

    Pain related to Portomar(TM) will be assessed using the same modified NCI PROMIS

  • Portomar(TM) pain intensity7 days after study begins with Portomar(TM) placement

    Pain related to Portomar(TM) will be assessed using the same modified NCI PROMIS

  • Portomar(TM) pain intensity14 days after study begins with Portomar(TM) placement

    Pain related to Portomar(TM) will be assessed using the same modified NCI PROMIS

  • Portomar(TM) pain intensity30 days after study begins with Portomar(TM) placement

    Pain related to Portomar(TM) will be assessed using the same modified NCI PROMIS

  • Portomar(TM) pain intensity90 days after study begins with Portomar(TM) placement

    Pain related to Portomar(TM) will be assessed using the same modified NCI PROMIS