Clinical trial NCT05583734: A Prospective Study of Conventional Bone Marrow Biopsy Versus Portomar(TM) Biopsy
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hematologic Malignancy
Lead sponsor: Aperture Medical Technology, LLC
Sponsor class: INDUSTRY
First posted: 2022-10-18
Enrollment: 32
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Self-controlled, prospective trial
Primary purpose: DIAGNOSTIC

Brief 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.

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

Primary outcomes:
measure: Pain intensity
timeFrame: Day of bone marrow biopsy (approximately 1 month after Portomar(TM) placement)
measure: Portomar(TM) pain intensity
timeFrame: Day of placement (beginning of study)
measure: Portomar(TM) pain intensity
timeFrame: 1 day after study begins with Portomar(TM) placement
measure: Portomar(TM) pain intensity
timeFrame: 2 days after study begins with Portomar(TM) placement
measure: Portomar(TM) pain intensity
timeFrame: 7 days after study begins with Portomar(TM) placement
measure: Portomar(TM) pain intensity
timeFrame: 14 days after study begins with Portomar(TM) placement
measure: Portomar(TM) pain intensity
timeFrame: 30 days after study begins with Portomar(TM) placement
measure: Portomar(TM) pain intensity
timeFrame: 90 days after study begins with Portomar(TM) placement
Secondary outcomes:
measure: Safety Events
timeFrame: Study duration, approximately 2 years
measure: Satisfaction Score
timeFrame: Day of placement and every time a bone marrow biopsy is performed using the Portomar(TM) device for study duration approximately 2 years
measure: Pain Score
timeFrame: Study duration (approximately 2 years) at all bone marrow biopsies with Portomar(TM)
measure: Specimen-Core Biopsy
timeFrame: Study duration (approximately 2 years) at all bone marrow biopsied performed with Portomar(TM)
measure: Specimen-Aspirate
timeFrame: Study duration (approximately 2 years) at all bone marrow biopsied performed with Portomar(TM)
measure: Time
timeFrame: Study duration (approximately 2 years) at all bone marrow biopsied performed with Portomar(TM)
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson
state: Texas
Study officials:
affiliation: MD Anderson
name: Rahul Sheth
role: PRINCIPAL_INVESTIGATOR
References: