Evaluating Effectiveness of Powered Drill Bone Marrow Biopsy
| Status: | Recruiting |
|---|---|
| Conditions: | Hematology, Hematology |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/17/2018 |
| Start Date: | February 14, 2017 |
| End Date: | March 31, 2020 |
| Contact: | Ajay Nooka, MD, MPH |
| Email: | anooka@emory.edu |
| Phone: | 404-778-4191 |
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
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.
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.
PRIMARY OBJECTIVES:
I. Assessing the quality and quantity of bone marrow core biopsies.
SECONDARY OBJECTIVES:
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.
I. Assessing the quality and quantity of bone marrow core biopsies.
SECONDARY OBJECTIVES:
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.
Inclusion Criteria:
- All patients with existing plasma cell disorders and no history of psychiatric
disorders who can receive conscious sedation are eligible to participate in the trial
Exclusion Criteria:
- Pregnant women are excluded from participating in this study
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