Prospective Bone Marrow Biopsy Safety and Efficacy Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Bone marrow biopsy is a frequently performed procedure to diagnose and evaluate hematologic diseases. It is estimated that over 700,000 bone marrow procedures (BMP's) are performed annually in the U.S. Most of them are performed by practicing hematologists/oncologists in their offices or hospitals. However, a significant number are performed by hematologists-in-training (H-I-T's) in teaching hospitals. However, the incidences of complications associated with bone marrow biopsy are largely unknown. This study has two goals:

1. The first goal is to objectively determine by CT and clinical assessment, the actual risk to patients of the bone marrow biopsy and the rate of pelvic injury in an unselected group of hematology patients requiring a bone marrow biopsy, as performed by hematologist-in-training.
2. The second goal is to determine the quality of bone marrow biopsies obtained, using the lateral angulation technique.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

National Marrow Donor Program Long-Term Donor Follow-Up

NCT01362179

Hematologic Neoplasms

COMPLETED

Landmark vs. Ultrasound-Assisted Bone Marrow Biopsy Procedure Study

NCT05258357

Bone Marrow Biopsy Procedure

ACTIVE_NOT_RECRUITING NA

Data Collection Study of Patients With Non-Malignant Disorders Undergoing UCBT, BMT or PBSCT With RIC

NCT04528355

Primary Immunodeficiency (PID) Congenital Bone Marrow Failure Syndromes Inherited Metabolic Disorders (IMD) +2 more

RECRUITING

Comparison of a Powered Bone Marrow Biopsy Device With a Manual System

NCT01535313

Bone Marrow Biopsy

COMPLETED NA

A Prospective Study of Conventional Bone Marrow Biopsy Versus Portomar(TM) Biopsy

NCT05583734

Hematologic Malignancy

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bone Marrow

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pelvis CT scan

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Subjects must have a hematological or oncological condition which requires a bone marrow aspiration and biopsy procedure, and no alternative procedures are available for diagnosis, staging, monitoring or follow up of their disease.
2. Subjects must be able to understand the risks/benefits and provide written informed consent to participate in the study, and be willing to participate in all required study activities for the duration of the study.
3. Subjects must be 40 years of age or older.

Exclusion Criteria

1. Patients unable to give consent because they are decisionally impaired or have a language barrier that cannot be overcome.
2. Psychiatric or cognitive illness or recreational drug/alcohol abuse that, in the opinion of the investigator would effect subject safety and/or compliance.
3. Patients with uncontrolled bleeding disorders.
4. Pregnant and lactating females (due to radiation exposure during the CT scans).

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No