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

Study Overview
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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.

Official Title
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A Trial of the Vidacare Powered Bone Marrow Aspiration and Core Biopsy Systems (OnControl by Vidacare) Compared to Traditional Manual Devices

Conditions
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Bone Marrow Biopsy Procedures

Intervention / Treatment
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* Device: OnControl Bone Marrow Biopsy and Aspiration System
* Device: Manual bone marrow sampling device


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Manual bone marrow sampling device<br>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<br>* 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.<br>* Other names: Manual biopsy needle;|
| Active Comparator: OnControl Bone Marrow System<br>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<br>* 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.<br>* Other names: Powered Biopsy Device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject Reported Level of Pain During Procedure | 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. | Day 1 during the needle insertion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time Necessary to Perform the Bone Marrow Procedure | 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. | Day 1 needle insertion through needle removal | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bone marrow biopsy of iliac crest