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

Vidacare

Status: Completed

Conditions: Bone Marrow Biopsy Procedures

Treatments: Device: OnControl Bone Marrow Biopsy and Aspiration System; Device: Manual bone marrow sampling device

Study type: Interventional

Funder types: Industry

Identifiers

NCT01312519

2007-04

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Manual bone marrow sampling device

Active Comparator group

Description:

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.

Treatment:

Device: Manual bone marrow sampling device

OnControl Bone Marrow System

Active Comparator group

Description:

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.

Treatment:

Device: OnControl Bone Marrow Biopsy and Aspiration System