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Ultrasound-Assisted vs. Landmark Bone Marrow Biopsy Techniques (LUMP Trial)
N/A
Recruiting
Led By Devin Madenberg, DO
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Inpatient at Froedtert & MCW Froedtert Hospital ≥18 years old
Bone marrow biopsy is being performed for the explicit purpose of hematology/oncology assessment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at the end of the study, estimated to be at 2 years. samples will be analyzed by a pathologist once all samples from 100 participants are obtained.
Awards & highlights
LUMP Trial Summary
This trial will compare outcomes of two different approaches to bone marrow biopsies - ultrasound vs landmarks - in order to determine which is more effective.
Who is the study for?
This trial is for adult patients at Froedtert Hospital who need a bone marrow biopsy for blood or cancer conditions and can give consent. It's not for those under 18, without a biopsy indication, with BMI ≥ 40, or unable to consent.Check my eligibility
What is being tested?
The study compares traditional palpation method versus ultrasound-assisted technique in performing bone marrow biopsies. It aims to see if using ultrasound improves the procedure by reducing pain and increasing sample quality.See study design
What are the potential side effects?
While the document doesn't specify side effects, generally bone marrow biopsies can cause pain at the puncture site, bleeding, bruising, infection risk and rarely long-lasting discomfort.
LUMP Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 or older and admitted to Froedtert & MCW Froedtert Hospital.
Select...
I am getting a bone marrow biopsy for cancer assessment.
LUMP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessed at the end of the study, estimated to be at 2 years.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed at the end of the study, estimated to be at 2 years.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Core adequacy
Secondary outcome measures
Aspirate adequacy
Complications
Drill attempts and pain correlation
+2 moreLUMP Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Ultrasound-AssistedExperimental Treatment1 Intervention
After the usual landmark technique is performed and the potential site has been marked, procedure team physician will use the ultrasound machine to "fine tune" the drill site location.
Group II: LandmarkActive Control1 Intervention
For a landmark bone marrow biopsy procedure, the patient is first positioned either prone or lateral decubitus. The lateral, superior iliac crest is palpated and an attempt is made to follow the course of the posterior iliac crest until the posterior superior iliac spine (PSIS) is palpated. Additionally, the gluteal cleft is visualized indicating the patient midline. The area over the sacrum at midline is then palpated, proceeding laterally until the PSIS can be felt. The skin is marked with a marker at the estimated PSIS and point of entry.
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Who is running the clinical trial?
Medical College of WisconsinLead Sponsor
609 Previous Clinical Trials
1,162,483 Total Patients Enrolled
Devin Madenberg, DOPrincipal InvestigatorMedical College of Wisconsin
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am under 18 and admitted to Froedtert & MCW Froedtert Hospital.I am 18 or older and admitted to Froedtert & MCW Froedtert Hospital.I am getting a bone marrow biopsy for cancer assessment.
Research Study Groups:
This trial has the following groups:- Group 1: Ultrasound-Assisted
- Group 2: Landmark
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 participants have thus far signed up to take part in the experiment?
"Affirmative, clinicaltrials.gov exhibits that this clinical trial is actively seeking participants. It was initially posted on May 18th 2022 and revised on 19th of the same month. The study requires 100 individuals to take part at one site."
Answered by AI
Is this research currently recruiting participants?
"Affirmative. Clinicaltrials.gov confirms that this trial, which had its initial posting on May 18th 2022, is enlisting individuals for participation. A total of 100 people are needed at one clinical site to complete the study."
Answered by AI
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