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NCT05258357 · ClinicalTrials.gov registry record · NA
Landmark vs. Ultrasound-Assisted Bone Marrow Biopsy Procedure Study
A NA study of Bone Marrow Biopsy Procedure, sponsored by Medical College of Wisconsin.
- Active
- Registry status
- NA
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT05258357 is a NA study of Bone Marrow Biopsy Procedure that is active but no longer recruiting, run by Medical College of Wisconsin. The registered enrollment target is 100 participants. The trial reports 1 study location across 1 state.
The verdict
NCT05258357, a NA study of Bone Marrow Biopsy Procedure, is active but no longer recruiting, sponsored by Medical College of Wisconsin.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study Summary
Bone marrow biopsies are routinely performed by the Medicine Bedside Procedure Team service at Froedtert Hospital. Typical indications for inpatient bone marrow biopsies include evaluations for cytopenia, leukemia, lymphoma, myelodysplastic syndrome, or plasma cell dyscrasia. The bone marrow is sampled from the posterior iliac crest, ideally by drilling into the posterior superior iliac spine (PSIS). The Arrow® OnControl® Powered Bone Access System is utilized for this process. Most frequently, the location of the PSIS is estimated by using palpation of landmarks, such as the lateral iliac crests, spinous processes, sacrum, and the PSIS itself. Additionally, when using lidocaine to anesthetize the site, the needle is maneuvered to locate the most superficial portion of the PSIS, confirming the optimal drill anchor site. The correct direction/angle of the drill is estimated based on the orientation of the patient, typically directing it perpendicular to the coronal plane. Palpating landmarks to identify the posterior superior iliac spine is often difficult due to patient body habitus. Ultrasonography allows for accurate identification of the PSIS. It allows the clinician to pinpoint the best entry point in the skin and optimal drill angle to drive the needle perpendicular to the coronal plane. Furthermore, it allows the clinician to measure the distance from the skin to the PSIS, ensuring the drill bit is anchored onto the correct site. The benefits of an ultrasound approach have not been well documented. Therefore, this study will seek to provide evidence of benefits, or lack thereof, in using ultrasound for bone marrow biopsies. This will be achieved using a two-arm, open-label, randomized study design which will compare patient outcomes, as measured by pain assessment, bone marrow biopsy procedure metrics, and bone marrow biopsy sample quality, between subjects that have undergone the procedure using either the control landmark palpation method or ultrasound-ass
Conditions Studied
Interventions
- DEVICE Ultrasound-assisted bone marrow biopsy
- PROCEDURE Landmark palpation bone marrow biopsy
Study Locations (1)
Wisconsin
- Froedtert Hospital - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2022-05-18 |
| Est. Completion | 2026-12-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05258357
The ClinicalTrials.gov registry entry for NCT05258357 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical College of Wisconsin, which has 447 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Bone Marrow Biopsy Procedure appearing as the primary indexed condition, and to 2 interventions - of which Ultrasound-assisted bone marrow biopsy is the first listed.
NCT05258357 reports 1 study location spanning 1 distinct geographic area - top geographies include Wisconsin.
Frequently Asked Questions
What is clinical trial NCT05258357 about?
NCT05258357 is a clinical study titled "Landmark vs. Ultrasound-Assisted Bone Marrow Biopsy Procedure Study". Bone marrow biopsies are routinely performed by the Medicine Bedside Procedure Team service at Froedtert Hospital. Typical indications for inpatient bone marrow biopsies include evaluations for cytopenia, leukemia, lymphoma, myelodysplastic syndrome, or plasma cell dyscrasia. The bone marrow is samp...
What is the current status of trial NCT05258357?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2022-05-18. Estimated completion is 2026-12-01.
What conditions does trial NCT05258357 study?
This clinical trial studies the following conditions: Bone Marrow Biopsy Procedure.
What interventions are being tested in trial NCT05258357?
The interventions under investigation include: Ultrasound-assisted bone marrow biopsy (DEVICE), Landmark palpation bone marrow biopsy (PROCEDURE).
Who is sponsoring clinical trial NCT05258357?
This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05258357 being conducted?
This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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