Evaluating Effectiveness of Powered Drill Bone Marrow Biopsy

NCT03078452 | Completed Results FDA Device

• 4 other identifiers: IRB00075658NCI-2017-00308Winship2656-14P30CA138292
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Plasma Cell Myeloma

Outcome Measures

Primary Outcomes (1)

• Bone Marrow Core Biopsy Length (in mm) and Artifacts Assessed by the Pathologist

  Bone marrow biopsy length is studied with mean, median, range, and standard deviation and compared by two-sample t-test.

  At the time of biopsy

Secondary Outcomes (2)

• Intensity of Pain Measured Using Visual Analogue Scale (VAS) Pain Questionnaire

  At the time of, 30 minutes, 1, 3, and 7 days after biopsy

• Time Taken by the Procedure Measured in Seconds Using a Stopwatch

  At the time of biopsy

Study Arms (2)

Arm I (biopsy using power drill)

EXPERIMENTAL

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

Arm II (biopsy using Jamshidi needle)

ACTIVE COMPARATOR

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

Interventions

Power drill DEVICE

Undergo bone marrow biopsy using power drill

Arm I (biopsy using power drill)

Jamshidi needle DEVICE

Undergo bone marrow biopsy using Jamshidi needle

Arm II (biopsy using Jamshidi needle)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant women are excluded from participating in this study

Sponsors & Collaborators

• Emory University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Emory University/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Dr. Ajay Nooka
• Organization: Emory University

anooka@emory.edu

404-778-1900

Study Officials

• Ajay Nooka, MD, MPH

  Emory University/Winship Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 10, 2017
• First Posted: March 13, 2017
• Study Start: February 14, 2017
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: September 8, 2025
• Results First Posted: September 8, 2025

Record last verified: 2025-08

Locations

US (1)