CompletedNot Applicable

A Study Comparing Use of Manual and Power Bone Marrow Aspiration and Biopsy Devices in Children

United States44 participantsStarted 2012-04

Plain-language summary

The purpose of this study is to compare use of a powered bone marrow aspiration and biopsy device (OnControl) to use of a standard manual bone marrow aspiration and biopsy device to obtain bone marrow biopsy specimens in children. The hypothesis is that use of the powered device will improve the quantity and quality of bone marrow biopsy specimens when compared to the manual device.

Who can participate

Age range

2 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Informed consent and assent for minors over the age of seven years must be obtained before any trial-related activities are initiated * Patients requiring bone marrow aspirations and/or biopsies as part of standard diagnosis and treatment * Treated at Christus Santa Rosa Children's hospital * Age 2 to 18 years * Male or female * Supportive family with willingness to participate in completing questionnaires * English or Spanish primary language Exclusion Criteria: * Patients who are pregnant * Patients with hemorrhagic disorders such as congenital coagulation factor deficiencies disseminated intravascular coagulation and concomitant use of anticoagulants * Patients with a skin infection or recent radiation therapy at the sampling site * Patients with bone disorders such as osteomyelitis or osteogenesis imperfecta

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percent of Hematopoietic Tissue Present in Bone Marrow Biopsy Specimens Obtained Using the Manual Device and Powered Device

Timeframe: within 24 hours of bone marrow sampling procedure

Trial details

NCT IDNCT02159118

SponsorVidacare Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-05

Results submitted2014-07-15

View on ClinicalTrials.gov More Bone Marrow Aspiration and Biopsy Specimen Collection trials