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Evaluating Effectiveness of Powered Drill Bone Marrow Biopsy

Primary Purpose

Plasma Cell Myeloma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Power drill
Jamshidi needle
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Plasma Cell Myeloma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Emory University/Winship Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm I (biopsy using power drill)

Arm II (biopsy using Jamshidi needle)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
March 10, 2017
Last Updated
May 30, 2023
Sponsor
Emory University
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1. Study Identification

Unique Protocol Identification Number
NCT03078452
Brief Title
Evaluating Effectiveness of Powered Drill Bone Marrow Biopsy
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 14, 2017 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plasma Cell Myeloma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm I (biopsy using power drill)
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm II (biopsy using Jamshidi needle)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Power drill
Intervention Description
Undergo bone marrow biopsy using power drill
Intervention Type
Device
Intervention Name(s)
Jamshidi needle
Intervention Description
Undergo bone marrow biopsy using Jamshidi needle
Primary Outcome Measure Information:
Title
Bone marrow core biopsy length (in mm) and artifacts assessed by the pathologist
Description
Bone marrow biopsy length is studied with mean, median, range, and standard deviation and compared by two-sample t-test.
Time Frame
At the time of biopsy
Secondary Outcome Measure Information:
Title
Intensity of pain measured using visual analogue scale (VAS) pain questionnaire
Description
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 Frame
At the time of, 30 minutes, 1, 3, and 7 days after biopsy
Title
Time taken by the procedure measured in seconds using a stopwatch
Description
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.
Time Frame
At the time of biopsy

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ajay Nooka, MD, MPH
Phone
404-778-4191
Email
anooka@emory.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ajay Nooka, MD, MPH
Organizational Affiliation
Emory University/Winship Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University/Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Shipp
Phone
404-778-4191
Email
jennifer.shipp@emory.edu
First Name & Middle Initial & Last Name & Degree
Eduardo Sanabria
Phone
404-778-2164
Email
esanab2@emory.edu

12. IPD Sharing Statement

Learn more about this trial

Evaluating Effectiveness of Powered Drill Bone Marrow Biopsy

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