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.
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
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
32
Portomar(TM) access device for bone marrow biopsy
MD Anderson
Houston, Texas, United States
RECRUITINGPain 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.
Time frame: 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).
Time frame: Day of placement (beginning of study)
Portomar(TM) pain intensity
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
Portomar(TM) pain intensity
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
Portomar(TM) pain intensity
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
Portomar(TM) pain intensity
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
Portomar(TM) pain intensity
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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
Portomar(TM) pain intensity
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
Safety Events
Adverse events
Time frame: Study duration, approximately 2 years
Satisfaction Score
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
Pain Score
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)
Specimen-Core Biopsy
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)
Specimen-Aspirate
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)
Time
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)