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Procedure
Powered Drill Biopsy for Multiple Myeloma
N/A
Recruiting
Led By Ajay Nooka, MD, MPH
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the time of biopsy
Awards & highlights
Study Summary
This trial is comparing the effectiveness of the battery-powered bone marrow biopsy system to the Jamshidi needle (the traditional manual) method of bone marrow sampling.
Who is the study for?
This trial is for patients with plasma cell disorders like multiple myeloma, who can undergo conscious sedation and have no psychiatric history. Pregnant women are not eligible to participate.Check my eligibility
What is being tested?
The study compares the effectiveness of a traditional manual Jamshidi needle versus a newer battery-powered drill for bone marrow biopsies in patients with conditions such as multiple myeloma.See study design
What are the potential side effects?
Potential side effects may include discomfort at the biopsy site, bleeding, bruising, or infection. The powered drill might also carry risks specific to its use but these are generally similar to those associated with manual biopsy methods.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at the time of biopsy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the time of biopsy
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Bone marrow core biopsy length (in mm) and artifacts assessed by the pathologist
Secondary outcome measures
Intensity of pain measured using visual analogue scale (VAS) pain questionnaire
Time taken by the procedure measured in seconds using a stopwatch
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (biopsy using power drill)Experimental Treatment1 Intervention
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.
Group II: Arm II (biopsy using Jamshidi needle)Active Control1 Intervention
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.
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Who is running the clinical trial?
Emory UniversityLead Sponsor
1,637 Previous Clinical Trials
2,560,416 Total Patients Enrolled
25 Trials studying Multiple Myeloma
1,879 Patients Enrolled for Multiple Myeloma
Ajay Nooka, MD, MPHPrincipal Investigator - Emory University/Winship Cancer Institute
Emory University Hospital, Emory University Hospital Midtown
Andhra Medical College (Medical School)
Canton Medical Educ Fndn (Residency)
2 Previous Clinical Trials
78 Total Patients Enrolled
2 Trials studying Multiple Myeloma
78 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a plasma cell disorder, no psychiatric history, and can be sedated while awake.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (biopsy using power drill)
- Group 2: Arm II (biopsy using Jamshidi needle)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals have signed up to participate in this experiment?
"Affirmative. The clinicaltrial.gov website indicates that this medical trial, which was originally posted on February 14th 2017, is actively searching for participants to enrol in the study. A total of 100 patients are needed from one site location."
Answered by AI
Is participation in this clinical experiment still being solicited?
"As indicated on clinicaltrials.gov, the recruitment phase of this trial is currently in progress; it was initially posted on February 14th 2017 and most recently revised on May 19th 2022."
Answered by AI
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