A Study Comparing Powered Ported Bone Marrow Aspiration Procedures to Manual Standard Bone Marrow Aspiration Procedures Using Healthy Volunteers

Vidacare

Status

Completed

Conditions

Healthy

Treatments

Device: Jamshidi Manual Standard Device

Device: OnControl Powered Ported Device

Study type

Interventional

Funder types

Industry

Identifiers

NCT02299102

2014-12 (Other Identifier)

Details and patient eligibility

About

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.

Full 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 volunteers for bone marrow aspiration specimen collection. The study will compare the quality of specimen yield of the devices, subject reported level of pain with needle insertion and aspiration, and time from needle/skin contact to needle insertion and to sample acquisition. Each subject will serve as his/her own control and will receive bilateral bone marrow aspiration procedures using both the manual standard and power ported needles. The order in which the devices are used for each subject's procedures and on which side each device will be used will be randomized.

Enrollment

15 patients

Sex

All

Ages

21 to 99 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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 criteria

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