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NCT03078452

Evaluating Effectiveness of Powered Drill Bone Marrow Biopsy

Completed NA Results posted Last updated 8 September 2025
What this trial tests

NA trial testing Power drill in Plasma Cell Myeloma in 100 participants. Completed in 1 December 2023.

Timeline
14 February 2017
Primary endpoint
1 December 2023
1 December 2023

Quick facts

Lead sponsorEmory University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposediagnostic
Enrollment100
Start date14 February 2017
Primary completion1 December 2023
Estimated completion1 December 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Emory University

Who can join

Eligibility, any sex, with Plasma Cell Myeloma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Bone Marrow Core Biopsy Length (in mm) and Artifacts Assessed by the Pathologist Primary · 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.

GroupValue95% CI
Arm I (Biopsy Using Power Drill)145 – 30
Arm II (Biopsy Using Jamshidi Needle)9.53 – 23
Intensity of Pain Measured Using Visual Analogue Scale (VAS) Pain Questionnaire Secondary · 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. The pain scale used was 0-10, with 0 being no pain and 10 being the worst pain.

30 minutes
GroupValue95% CI
Arm I (Biopsy Using Power Drill).660 – 6
Arm II (Biopsy Using Jamshidi Needle).840 – 8
1 day after biopsy
GroupValue95% CI
Arm I (Biopsy Using Power Drill)1.620 – 10
Arm II (Biopsy Using Jamshidi Needle)1.620 – 10
3 days after biopsy
GroupValue95% CI
Arm I (Biopsy Using Power Drill).890 – 8
Arm II (Biopsy Using Jamshidi Needle).630 – 5
7 days after biopsy
GroupValue95% CI
Arm I (Biopsy Using Power Drill).180 – 5
Arm II (Biopsy Using Jamshidi Needle).260 – 5
Time Taken by the Procedure Measured in Seconds Using a Stopwatch Secondary · 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.

GroupValue95% CI
Arm I (Biopsy Using Power Drill)73 – 24
Arm II (Biopsy Using Jamshidi Needle)10.54 – 30

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Plasma Cell Myeloma

Currently open trials in the same condition.

Other Emory University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03078452.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing