Evaluating Effectiveness of Powered Drill Bone Marrow Biopsy
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|ClinicalTrials.gov Identifier: NCT03078452|
Recruitment Status : Recruiting
First Posted : March 13, 2017
Last Update Posted : May 9, 2019
Since the introduction of the Jamshidi needle in 1971, new advances in bone marrow sampling have not been seen. In 2007, a new battery-powered bone marrow biopsy system was developed. This technology, using a battery-powered drill to operate the needle accessing the posterior iliac bone, was approved by the Food and Drug Administration (FDA) and is currently commercially available.
Few randomized controlled trials (RCTs) have compared the use of the battery-powered bone marrow biopsy system to the Jamshidi needle (the traditional manual) method of bone marrow sampling. This research study is designed to evaluate the effectiveness of the Jamshidi needle compared to the battery-powered bone marrow biopsy system.
100 participants will be enrolled in this study at Emory University.
|Condition or disease||Intervention/treatment||Phase|
|Plasma Cell Myeloma||Device: Power drill Device: Jamshidi needle||Not Applicable|
I. Assessing the quality and quantity of bone marrow core biopsies.
I. Assessing the nature of pain by established visual analogue scale (VAS) questionnaires.
II. Timing of the actual procedure.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo bone marrow biopsy using the power drill.
ARM II: Patients undergo bone marrow biopsy using the traditional Jamshidi needle.
All patients complete questionnaires at baseline, 30 minutes after biopsy, and on days 1, 3, and 7.
After completion of study treatment, patients are followed up periodically.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of Quality of Bone Marrow Biopsy and Patient Convenience and Pain Control by a Battery Powered Drill Versus Conventional Methods in Patients With Plasma Cell Disorders|
|Actual Study Start Date :||February 14, 2017|
|Estimated Primary Completion Date :||May 31, 2021|
|Estimated Study Completion Date :||May 31, 2022|
Experimental: Arm I (biopsy using power drill)
Patients undergo bone marrow biopsy using the power drill. Patients complete questionnaires at baseline, 30 minutes after biopsy, and on days 1, 3, and 7.
Device: Power drill
Undergo bone marrow biopsy using power drill
Active Comparator: Arm II (biopsy using Jamshidi needle)
Patients undergo bone marrow biopsy using the traditional Jamshidi needle. Patients complete questionnaires at baseline, 30 minutes after biopsy, and on days 1, 3, and 7.
Device: Jamshidi needle
Undergo bone marrow biopsy using Jamshidi needle
- Bone marrow core biopsy length (in mm) and artifacts assessed by the pathologist [ Time Frame: At the time of biopsy ]Bone marrow biopsy length is studied with mean, median, range, and standard deviation and compared by two-sample t-test.
- Intensity of pain measured using visual analogue scale (VAS) pain questionnaire [ Time Frame: At the time of, 30 minutes, 1, 3, and 7 days after biopsy ]The VAS (visual analogue scale) for pain is on a 10 point scale. Pain is studied with chi-square, Mann Whitney U test, or Fisher's exact test.
- Time taken by the procedure measured in seconds using a stopwatch [ Time Frame: At the time of biopsy ]Staff members will use a stopwatch from the beginning to the completion of the procedure (skin to skin). Time taken for procedure is studied with mean, median, range, and standard deviation and compared by two-sample t-test.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03078452
|Contact: Ajay Nooka, MD, MPHfirstname.lastname@example.org|
|United States, Georgia|
|Emory University/Winship Cancer Institute||Recruiting|
|Atlanta, Georgia, United States, 30322|
|Contact: Jennifer Shipp 404-778-4191 email@example.com|
|Contact: Eduardo Sanabria 404-778-2164 firstname.lastname@example.org|
|Principal Investigator:||Ajay Nooka, MD, MPH||Emory University/Winship Cancer Institute|