Comparing Powered Ported Bone Marrow Aspiration to Manual Standard Bone Marrow Aspiration Procedures

NCT02299102 | Completed Results

• 1 other identifier: 2014-12
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This single center study 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 evaluate the subjects' perceived level of pain, time to sample acquisition, and quality of specimen yield of these devices. Each subject will receive bilateral bone marrow aspiration procedures using both the manual standard and powered ported devices.

Conditions

Healthy

Keywords

Aspiration Procedures; Bone Marrow; powered ported bone marrow aspiration procedures

Outcome Measures

Primary Outcomes (2)

• Quality of Aspirate Specimen Yield Total Score -Jamshidi Manual Standard Device

  The Quality of Aspirate Specimen Yield Total Score is a sum score using the 3 quality rating scales below. The Score range: 0 to 8; Higher scores mean greater quality. Direct Smears- Cellularity: 0= obviously dilute, no good particles or adequate megakaryocytes (MK) 1. probably slightly dilute, particles and MK present 2. cellular, good particles; MK present on edge, smears reflect clot section cellularity Particle Crush Smears: Evaluate presence of particles and quality of cellularity: 0= no particles 1. few particles; difficult to evaluate marrow cellularity and adequacy of MK 2. good particles; adequate material to evaluate MK 3. many particles, some large, with MK easily evaluated Clot Sections: Evaluate quantity and quality of particles 0= insufficient or no particles for interpretation 1. few small particles; difficult to determine cellularity 2. several particles, good marrow cellularity 3. numerous particles (some large); easy to assess cellularity and cell composition

  analyzed and results received within 30 days of Day 1 procedures

• Quality of Aspirate Specimen Yield Total Score -OnControl Power Ported Device

  The Quality of Aspirate Specimen Yield Total Score is a sum score using the 3 quality rating scales below. The Score range: 0 to 8; Higher scores mean greater quality. Direct Smears- Cellularity: 0= obviously dilute, no good particles or adequate megakaryocytes (MK) 1. probably slightly dilute, particles and MK present 2. cellular, good particles; MK present on edge, smears reflect clot section cellularity Particle Crush Smears: Evaluate presence of particles and quality of cellularity: 0= no particles 1. few particles; difficult to evaluate marrow cellularity and adequacy of MK 2. good particles; adequate material to evaluate MK 3. many particles, some large, with MK easily evaluated Clot Sections: Evaluate quantity and quality of particles 0= insufficient or no particles for interpretation 1. few small particles; difficult to determine cellularity 2. several particles, good marrow cellularity 3. numerous particles (some large); easy to assess cellularity and cell composition

  analyzed and results received within 30 days of Day 1 procedures

Secondary Outcomes (8)

• Level of Pain With Needle Insertion- Jamshidi Manual Standard Device

  Day 1 at time of procedure

• Level of Pain With Needle Insertion- OnControl Power Ported Device

  Day 1 at time of procedure

• Level of Pain With Aspiration - Jamshidi Manual Standard Device

  1 Day at time of the procedure

• Level of Pain With Aspiration - OnControl Power Ported Device

  1 Day at time of the procedure

• Time to Insertion - Jamshidi Manual Standard Device

  1 Day, during procedure

Study Arms (2)

Group 1: First Procedure: Jamshidi Manual Standard Device

OTHER

The Jamshidi manual standard device procedure will be performed first. The OnControl Powered Ported device procedure will be performed second.

Device: Jamshidi Manual Standard Device; Device: OnControl Powered Ported Device

Group 2: First Procedure OnControl Powered Ported Device

OTHER

The OnControl power ported device procedure will be performed first. The Jamshidi manual standard device procedure will be performed second.

Device: Jamshidi Manual Standard Device; Device: OnControl Powered Ported Device

Interventions

Jamshidi Manual Standard Device DEVICE

Jamshidi Manual Standard Device

Group 1: First Procedure: Jamshidi Manual Standard Device; Group 2: First Procedure OnControl Powered Ported Device

OnControl Powered Ported Device DEVICE

OnControl Powered Ported Device

Group 1: First Procedure: Jamshidi Manual Standard Device; Group 2: First Procedure OnControl Powered Ported Device

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vidacare Corporation: lead

Study Sites (1)

Medical Therapy and Research LLC.

San Antonio, Texas, 78217, United States

Location

Results Point of Contact

• Title: Tatiana Puga
• Organization: Teleflex

tatiana.puga@teleflex.com

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subject were randomized to determine which device procedure was performed first. Subjects randomized to Group 1 received the Jamshidi Manual Standard device procedure first and the OnControl Powered Ported device procedure second. Subjects ranomized to Group 2 received the OnControl Powered Ported device procedure first and the Jamshidi Manual Standard device procedure second.

Study Record Dates

• First Submitted: November 17, 2014
• First Posted: November 24, 2014
• Study Start: December 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 29, 2026
• Results First Posted: May 29, 2026

Record last verified: 2016-12

Locations

US (1)