Powered Bone Marrow Aspiration and Core Biopsy System Compared to Manual Devices
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01312519|
Recruitment Status : Completed
First Posted : March 10, 2011
Results First Posted : July 23, 2013
Last Update Posted : August 7, 2013
|Condition or disease||Intervention/treatment||Phase|
|Bone Marrow Biopsy Procedures||Device: OnControl Bone Marrow Biopsy and Aspiration System Device: Manual bone marrow sampling device||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Trial of the Vidacare Powered Bone Marrow Aspiration and Core Biopsy Systems (OnControl by Vidacare) Compared to Traditional Manual Devices|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||July 2010|
|Actual Study Completion Date :||August 2010|
Active Comparator: 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.
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.
Active Comparator: 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.
Device: 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.
- Subject Reported Level of Pain During Procedure [ Time Frame: Day 1 during the needle insertion ]Subjects were asked to rate the level of pain they experienced during the procedure for needle insertion, following penetration of the cortex. A 0 to 10 pain scale was used where 0=no pain and 10= worst possible pain.
- Time Necessary to Perform the Bone Marrow Procedure [ Time Frame: Day 1 needle insertion through needle removal ]The time necessary to perform the procedure was measured as follows: Time started once the needle and skin came into contact and time stopped once the sample was collected and the needle was removed from the patient.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01312519
|United States, Texas|
|Cancer Therapy and Research Center|
|San Antonio, Texas, United States, 78229|
|Hospital General Universitario Gregorio Maranon|
|Madrid, Spain, 28007|
|Study Director:||Thomas Philbeck, PhD||Vidacare Corporation|