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

Hematologic Malignancy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05583734
• Other study ID #: Study Number: 1339403
• Status: Recruiting
• Phase: N/A
• Start date: November 22, 2022
• Est. completion date: October 2025

Study information

• Verified date: April 2024
• Source: Aperture Medical Technology, LLC
• Contact: S Solomon
• Phone: 6468663882
• Email: info[@]aperturemed.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hematologic Malignancy
• Hematologic Neoplasms

Intervention

Device:
• Portomar(TM) Device
Portomar(TM) access device for bone marrow biopsy

Locations

Country	Name	City	State
United States	MD Anderson	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Aperture Medical Technology, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Safety Events	Adverse events	Study duration, approximately 2 years
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)