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Powered Bone Marrow Aspiration and Core Biopsy System Compared to Manual Devices

NCT ID: NCT01312519

Last Updated: 2013-08-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-08-31

Brief Summary

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This is a randomized study evaluating use of a powered bone marrow biopsy and aspiration system (OnControl by Vidacare) compared to traditional manual devices. The hypothesis is that the powered system will reduce the level of patient pain during the aspiration and core biopsy procedures and the amount of time needed to perform the procedures.

Detailed Description

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Conditions

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Bone Marrow Biopsy Procedures

Keywords

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Bone marrow biopsy of iliac crest

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Manual bone marrow sampling device

Hollow needle with a t-shaped handle manually pushed into the bone for the purpose of bone marrow aspiration and core biopsy collection. Manual Bone Marrow Sampling Device.

Group Type ACTIVE_COMPARATOR

Manual bone marrow sampling device

Intervention Type DEVICE

Hollow needle with a t-shaped handle that is pushed into the bone for the purpose of collecting bone marrow aspiration and core biopsy samples.

OnControl Bone Marrow System

Battery powered device used for insertion of a single lumen catheter into the intraosseous space of the adult iliac crest. OnControl Bone Marrow Biopsy and Aspiration System.

Group Type ACTIVE_COMPARATOR

OnControl Bone Marrow Biopsy and Aspiration System

Intervention Type DEVICE

Battery powered device used for insertion of a single lumen catheter into the intraosseous space of the adult iliac crest for the purpose of aspiration and core biopsy collection.

Interventions

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OnControl Bone Marrow Biopsy and Aspiration System

Battery powered device used for insertion of a single lumen catheter into the intraosseous space of the adult iliac crest for the purpose of aspiration and core biopsy collection.

Intervention Type DEVICE

Manual bone marrow sampling device

Hollow needle with a t-shaped handle that is pushed into the bone for the purpose of collecting bone marrow aspiration and core biopsy samples.

Intervention Type DEVICE

Other Intervention Names

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OnControl Powered Biopsy Device Jamshidi Manual biopsy needle

Eligibility Criteria

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Inclusion Criteria

* Adults over the age of 18
* Patients that require core biopsy alone, or core biopsy and bone marrow aspiration

Exclusion Criteria

* Imprisoned
* Pregnant
* Cognitively impaired
* Requiring english language translation other than Spanish
* Patients with one or more conditions precluding bone marrow core biopsy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vidacare Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Philbeck, PhD

Role: STUDY_DIRECTOR

Vidacare Corporation

Locations

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Cancer Therapy and Research Center

San Antonio, Texas, United States

Site Status

Hospital General Universitario Gregorio Maranon

Madrid, , Spain

Site Status

Countries

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United States Spain

Other Identifiers

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2007-04

Identifier Type: -

Identifier Source: org_study_id