Evaluating Effectiveness of Powered Drill Bone Marrow Biopsy

Plasma Cell Myeloma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03078452
• Other study ID #: IRB00075658
• Secondary ID: NCI-2017-00308Wi
• Status: Completed
• Phase: N/A
• Start date: February 14, 2017
• Est. completion date: December 1, 2023

Study information

• Verified date: May 2024
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

PRIMARY OBJECTIVE:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Plasma Cell Myeloma

Intervention

Device:
• Power drill
Undergo bone marrow biopsy using power drill
• Jamshidi needle
Undergo bone marrow biopsy using Jamshidi needle

Locations

Country	Name	City	State
United States	Emory University/Winship Cancer Institute	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Intensity of pain measured using visual analogue scale (VAS) pain questionnaire	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.	At the time of, 30 minutes, 1, 3, and 7 days after biopsy
Secondary	Time taken by the procedure measured in seconds using a stopwatch	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.	At the time of biopsy