Completed

NCT Number: NCT01312519

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

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.

Completed

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Key information

Conditions

Bone Marrow Biopsy Procedures

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital General Universitario Gregorio Maranon, Madrid, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OnControl Bone Marrow Biopsy and Aspiration System

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.

Other names: OnControl, Powered Biopsy Device

Manual bone marrow sampling device

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.

Other names: Jamshidi, Manual biopsy needle

Primary outcomes

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.

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

Vidacare Corporation

Industry

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2010
Study completion: 2010
First posted: Mar 10, 2011
Registry last updated: Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.