Back to resultsA Prospective Study of Conventional Bone Marrow Biopsy Versus Portomar(TM) Biopsy
Primary Purpose
Hematologic Malignancy
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Portomar(TM) Device
Sponsored by
About this trial
This is an interventional diagnostic trial for Hematologic Malignancy
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Portomar(TM) Device
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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).
Portomar(TM) pain intensity
Pain related to Portomar(TM) will be assessed using the same modified NCI PROMIS
Portomar(TM) pain intensity
Pain related to Portomar(TM) will be assessed using the same modified NCI PROMIS
Portomar(TM) pain intensity
Pain related to Portomar(TM) will be assessed using the same modified NCI PROMIS
Portomar(TM) pain intensity
Pain related to Portomar(TM) will be assessed using the same modified NCI PROMIS
Portomar(TM) pain intensity
Pain related to Portomar(TM) will be assessed using the same modified NCI PROMIS
Portomar(TM) pain intensity
Pain related to Portomar(TM) will be assessed using the same modified NCI PROMIS
Secondary Outcome Measures
Safety Events
Adverse events
Satisfaction Score
Patient and practitioner satisfaction questionnaires
Pain Score
Pain from Portomar(TM) and bone marrow biopsies. The modified PROMIS scale 0-10 will be used.
Specimen-Core Biopsy
Adequacy. This will be judged by the proportion of biopsies at least 1.2 cm length.
Specimen-Aspirate
Adequacy This will be judged by the proportion of aspirations with at least 1 spicule seen.
Time
Time from needle anesthetic to sample acquired. Comparison of conventional vs. Portomar(TM).
Full Information
NCT ID
NCT05583734
First Posted
September 29, 2022
Last Updated
October 13, 2022
Sponsor
Aperture Medical Technology, LLC
1. Study Identification
Unique Protocol Identification Number
NCT05583734
Brief Title
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
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2022 (Anticipated)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
October 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aperture Medical Technology, LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematologic Malignancy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Self-controlled, prospective trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Portomar(TM) Device
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Portomar(TM) Device
Intervention Description
Portomar(TM) access device for bone marrow biopsy
Primary Outcome Measure Information:
Title
Pain intensity
Description
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.
Time Frame
Day of bone marrow biopsy (approximately 1 month after Portomar(TM) placement)
Title
Portomar(TM) pain intensity
Description
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).
Time Frame
Day of placement (beginning of study)
Title
Portomar(TM) pain intensity
Description
Pain related to Portomar(TM) will be assessed using the same modified NCI PROMIS
Time Frame
1 day after study begins with Portomar(TM) placement
Title
Portomar(TM) pain intensity
Description
Pain related to Portomar(TM) will be assessed using the same modified NCI PROMIS
Time Frame
2 days after study begins with Portomar(TM) placement
Title
Portomar(TM) pain intensity
Description
Pain related to Portomar(TM) will be assessed using the same modified NCI PROMIS
Time Frame
7 days after study begins with Portomar(TM) placement
Title
Portomar(TM) pain intensity
Description
Pain related to Portomar(TM) will be assessed using the same modified NCI PROMIS
Time Frame
14 days after study begins with Portomar(TM) placement
Title
Portomar(TM) pain intensity
Description
Pain related to Portomar(TM) will be assessed using the same modified NCI PROMIS
Time Frame
30 days after study begins with Portomar(TM) placement
Title
Portomar(TM) pain intensity
Description
Pain related to Portomar(TM) will be assessed using the same modified NCI PROMIS
Time Frame
90 days after study begins with Portomar(TM) placement
Secondary Outcome Measure Information:
Title
Safety Events
Description
Adverse events
Time Frame
Study duration, approximately 2 years
Title
Satisfaction Score
Description
Patient and practitioner satisfaction questionnaires
Time Frame
Day of placement and every time a bone marrow biopsy is performed using the Portomar(TM) device for study duration approximately 2 years
Title
Pain Score
Description
Pain from Portomar(TM) and bone marrow biopsies. The modified PROMIS scale 0-10 will be used.
Time Frame
Study duration (approximately 2 years) at all bone marrow biopsies with Portomar(TM)
Title
Specimen-Core Biopsy
Description
Adequacy. This will be judged by the proportion of biopsies at least 1.2 cm length.
Time Frame
Study duration (approximately 2 years) at all bone marrow biopsied performed with Portomar(TM)
Title
Specimen-Aspirate
Description
Adequacy This will be judged by the proportion of aspirations with at least 1 spicule seen.
Time Frame
Study duration (approximately 2 years) at all bone marrow biopsied performed with Portomar(TM)
Title
Time
Description
Time from needle anesthetic to sample acquired. Comparison of conventional vs. Portomar(TM).
Time Frame
Study duration (approximately 2 years) at all bone marrow biopsied performed with Portomar(TM)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
S Solomon
Phone
6468663882
Email
info@aperturemed.com
First Name & Middle Initial & Last Name or Official Title & Degree
Bob Rioux
Phone
508 561 7491
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elisabet Manasanch
Organizational Affiliation
MD Anderson
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
A Prospective Study of Conventional Bone Marrow Biopsy Versus Portomar(TM) Biopsy
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