Status:
COMPLETED
A Study Comparing Powered Ported Bone Marrow Aspiration Procedures to Manual Standard Bone Marrow Aspiration Procedures Using Healthy Volunteers
Lead Sponsor:
Vidacare Corporation
Conditions:
Healthy
Eligibility:
All Genders
21-99 years
Phase:
NA
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 health...
Detailed Description
This single center, randomized, controlled trial will compare the manual standard bone marrow aspiration needle to the power ported aspiration needle for use in the posterior iliac crest of healthy vo...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT02299102
Start Date
December 1 2014
End Date
December 1 2014
Last Update
December 7 2016
Active Locations (1)
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1
Medical Therapy and Research LLC.
San Antonio, Texas, United States, 78217