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

NCT ID: NCT02299102

Last Updated: 2016-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2014-12-31

Brief Summary

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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

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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

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Healthy

Keywords

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Aspiration Procedures Bone Marrow To compare powered ported bone marrow aspiration procedures to manual standard bone marrow aspiration procedures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Jamshidi Manual Standard Device

The Jamshidi manual standard device will be randomized for use on the right or left iliac crest

Group Type OTHER

Jamshidi Manual Standard Device

Intervention Type DEVICE

Jamshidi Manual Standard Device

OnControl Powered Ported Device

The OnControl power ported device will be used on the opposite iliac crest

Group Type OTHER

OnControl Powered Ported Device

Intervention Type DEVICE

OnControl Powered Ported Device

Interventions

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Jamshidi Manual Standard Device

Jamshidi Manual Standard Device

Intervention Type DEVICE

OnControl Powered Ported Device

OnControl Powered Ported Device

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vidacare Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Medical Therapy and Research LLC.

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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2014-12

Identifier Type: -

Identifier Source: org_study_id