Clinical trial NCT02299102: A Study Comparing Powered Ported Bone Marrow Aspiration Procedures to Manual Standard Bone Marrow Aspiration Procedures Using Healthy Volunteers
Official title: A Study Comparing Powered Ported Bone Marrow Aspiration Procedures to Manual Standard Bone Marrow Aspiration Procedures Using Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Aspiration Procedures
Bone Marrow
To compare powered ported bone marrow aspiration procedures to manual standard bone marrow aspiration procedures
Lead sponsor: Vidacare Corporation
Sponsor class: INDUSTRY
First posted: 2014-11-24
Enrollment: 15
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of aspirate specimen yield
timeFrame: 30 days
Secondary outcomes:
measure: Subject reported level of pain with needle insertion
timeFrame: 1 Day
measure: Subject reported level of pain with aspiration
timeFrame: 1 Day
measure: Time from needle/periosteum contact to needle insertion through the cortex
timeFrame: 1 Day
measure: Time from needle/periosteum contact to removal of the needle following sample acquisition
timeFrame: 1 Day
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Medical Therapy and Research LLC.
state: Texas
Study officials:
References: