NCT02299102

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Vidacare Corporation · Industry
• Sex: All
• Age: 21 Years – 99 Years
• Healthy volunteers: Accepted

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.

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 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.

Conditions

• Healthy

Interventions

Type	Name	Description
DEVICE	Jamshidi Manual Standard Device	Jamshidi Manual Standard Device
DEVICE	OnControl Powered Ported Device	OnControl Powered Ported Device

Timeline

• Start date: 2014-12-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2014-11-24
• Last updated: 2016-12-07

Locations

1 site across 1 country: United States