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Trial record 24 of 1808 for:    "bone marrow" | Recruiting, Not yet recruiting Studies

Evaluating Effectiveness of Powered Drill Bone Marrow Biopsy

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ClinicalTrials.gov Identifier: NCT03078452
Recruitment Status : Recruiting
First Posted : March 13, 2017
Last Update Posted : May 9, 2019
Sponsor:
Information provided by (Responsible Party):
Ajay Nooka, Emory University

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.


Condition or disease Intervention/treatment Phase
Plasma Cell Myeloma Device: Power drill Device: Jamshidi needle Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : February 14, 2017
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : May 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
Experimental: Arm I (biopsy using power drill)
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
Undergo bone marrow biopsy using power drill

Active Comparator: Arm II (biopsy using Jamshidi needle)
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
Undergo bone marrow biopsy using Jamshidi needle




Primary Outcome Measures :
  1. Bone marrow core biopsy length (in mm) and artifacts assessed by the pathologist [ Time Frame: 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.


Secondary Outcome Measures :
  1. Intensity of pain measured using visual analogue scale (VAS) pain questionnaire [ Time Frame: 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.

  2. Time taken by the procedure measured in seconds using a stopwatch [ Time Frame: 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03078452


Contacts
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Contact: Ajay Nooka, MD, MPH 404-778-4191 anooka@emory.edu

Locations
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United States, Georgia
Emory University/Winship Cancer Institute Recruiting
Atlanta, Georgia, United States, 30322
Contact: Jennifer Shipp    404-778-4191    jennifer.shipp@emory.edu   
Contact: Eduardo Sanabria    404-778-2164    esanab2@emory.edu   
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: Ajay Nooka, MD, MPH Emory University/Winship Cancer Institute

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Responsible Party: Ajay Nooka, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT03078452     History of Changes
Other Study ID Numbers: IRB00075658
NCI-2017-00308 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Winship2656-14 ( Other Identifier: Emory University/Winship Cancer Institute )
First Posted: March 13, 2017    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases