A Study Comparing Powered Ported Bone Marrow Aspiration Procedures to Manual Standard Bone Marrow Aspiration Procedures Using Healthy Volunteers
1 other identifier
interventional
15
1 country
1
Brief Summary
This single center, randomized, controlled trial will compare the manual standard bone marrow aspiration device to the powered ported bone marrow aspiration device for use in the iliac crest in healthy adult volunteers. The study will compare the subjects' perceived level of pain, time to sample acquisition, and quality of specimen yield of these devices. To serve as their own control, each subject will receive bilateral bone marrow aspiration procedures using both the manual standard and powered ported devices.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable healthy
Started Dec 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 17, 2014
CompletedFirst Posted
Study publicly available on registry
November 24, 2014
CompletedStudy Start
First participant enrolled
December 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedDecember 7, 2016
December 1, 2016
Same day
November 17, 2014
December 5, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Quality of aspirate specimen yield
Determined by a pathologist unaware of the device type used to obtain the specimen. The stained bone marrow aspirate smears will be evaluated for the presence of bone marrow particles (spicules) as well as the relative cellularity and quality of the bone marrow cells present in the smears.
30 days
Secondary Outcomes (4)
Subject reported level of pain with needle insertion
1 Day
Subject reported level of pain with aspiration
1 Day
Time from needle/periosteum contact to needle insertion through the cortex
1 Day
Time from needle/periosteum contact to removal of the needle following sample acquisition
1 Day
Study Arms (2)
Jamshidi Manual Standard Device
OTHERThe Jamshidi manual standard device will be randomized for use on the right or left iliac crest
OnControl Powered Ported Device
OTHERThe OnControl power ported device will be used on the opposite iliac crest
Interventions
Eligibility Criteria
You may qualify if:
- Adults 21 years of age and over
- Able to lay flat in prone position on a table for up to 1 hour
- Self-reported as healthy, as confirmed by the investigator during the medical history review and physical examination
- Female subjects with a negative urine pregnancy test at screening visit
You may not qualify if:
- Reported fever within 7 days of the screening visit
- Reported active infection within 7 days of the screening visit
- Fever on day of study procedure
- Signs/symptoms of active infection on day of study procedure
- Imprisoned
- Self identified as pregnant or lactating
- Cognitively impaired
- Patients with one or more conditions precluding bone marrow aspiration
- Excessive tissue and/or absence of adequate anatomical landmarks in target bone
- Allergy to local anesthetics
- Unable to lay flat in prone position
- Prothrombin time and International Normalized Ratio (PT/INR) results outside of normal range on screening lab work and deemed clinically significant by the investigator
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical Therapy and Research LLC.
San Antonio, Texas, 78217, United States
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 17, 2014
First Posted
November 24, 2014
Study Start
December 1, 2014
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
December 7, 2016
Record last verified: 2016-12