A Prospective Study of Conventional Bone Marrow Biopsy Versus 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 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.

Study Overview

• Status: Recruiting
• Conditions: Hematologic Malignancy
• Intervention / Treatment: Device: Portomar(TM) Device

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.

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: S Solomon; Phone Number: 6468663882; Email: info@aperturemed.com
• Study Contact Backup: Name: Bob Rioux; Phone Number: 508 561 7491

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • MD Anderson
      • Contact: Rahul Sheth, MD; Phone Number: 713-745-4794

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Portomar(TM) Device; Portomar(TM) Device for bone marrow biopsy Subjects are self-controlled with one side having conventional biopsy and the other having the Portomar(TM) biopsy.	Device: Portomar(TM) Device; Portomar(TM) access device for bone marrow biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	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.	Day of bone marrow biopsy (approximately 1 month after Portomar(TM) placement)
Portomar(TM) pain intensity	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).	Day of placement (beginning of study)
Portomar(TM) pain intensity	Pain related to Portomar(TM) will be assessed using the same modified NCI PROMIS	1 day after study begins with Portomar(TM) placement
Portomar(TM) pain intensity	Pain related to Portomar(TM) will be assessed using the same modified NCI PROMIS	2 days after study begins with Portomar(TM) placement
Portomar(TM) pain intensity	Pain related to Portomar(TM) will be assessed using the same modified NCI PROMIS	7 days after study begins with Portomar(TM) placement
Portomar(TM) pain intensity	Pain related to Portomar(TM) will be assessed using the same modified NCI PROMIS	14 days after study begins with Portomar(TM) placement
Portomar(TM) pain intensity	Pain related to Portomar(TM) will be assessed using the same modified NCI PROMIS	30 days after study begins with Portomar(TM) placement
Portomar(TM) pain intensity	Pain related to Portomar(TM) will be assessed using the same modified NCI PROMIS	90 days after study begins with Portomar(TM) placement

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Events	Adverse events	Study duration, approximately 2 years
Satisfaction Score	Patient and practitioner satisfaction questionnaires	Day of placement and every time a bone marrow biopsy is performed using the Portomar(TM) device for study duration approximately 2 years
Pain Score	Pain from Portomar(TM) and bone marrow biopsies. The modified PROMIS scale 0-10 will be used.	Study duration (approximately 2 years) at all bone marrow biopsies with Portomar(TM)
Specimen-Core Biopsy	Adequacy. This will be judged by the proportion of biopsies at least 1.2 cm length.	Study duration (approximately 2 years) at all bone marrow biopsied performed with Portomar(TM)
Specimen-Aspirate	Adequacy This will be judged by the proportion of aspirations with at least 1 spicule seen.	Study duration (approximately 2 years) at all bone marrow biopsied performed with Portomar(TM)
Time	Time from needle anesthetic to sample acquired. Comparison of conventional vs. Portomar(TM).	Study duration (approximately 2 years) at all bone marrow biopsied performed with Portomar(TM)

Collaborators and Investigators

• Sponsor: Aperture Medical Technology, LLC
• Investigators: Principal Investigator: Rahul Sheth, MD Anderson

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2022
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: September 29, 2022
• First Submitted That Met QC Criteria: October 13, 2022
• First Posted (Actual): October 18, 2022

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 21, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Hematologic Diseases; Hematologic Neoplasms
• Other Study ID Numbers: Study Number: 1339403

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes