Bone Marrow Biopsy ProceduresNCT01312519
Powered Bone Marrow Aspiration and Core Biopsy System Compared to Manual Devices
A study testing Manual bone marrow sampling device in people with Bone Marrow Biopsy Procedures, run by Vidacare Corporation at 2 sites in 2 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Marrow Biopsy Procedures
- What is being tested?
- Manual bone marrow sampling device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jan 2010to Aug 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults over the age of 18
- Patients that require core biopsy alone, or core biopsy and bone marrow aspiration
Who cannot join
- Imprisoned
- Pregnant
- Cognitively impaired
- Requiring english language translation other than Spanish
- Patients with one or more conditions precluding bone marrow core biopsy
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Cancer Therapy and Research Center
San Antonio, Texas, 78229
About this study
Official title: A Trial of the Vidacare Powered Bone Marrow Aspiration and Core Biopsy Systems (OnControl by Vidacare) Compared to Traditional 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.
- Conditions
- Bone Marrow Biopsy Procedures
- Being tested
- OnControl Bone Marrow Biopsy and Aspiration System, Manual bone marrow sampling device
- Keywords
- Bone marrow biopsy of iliac crest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OnControl Bone Marrow Biopsy and Aspiration SystemDevice
Also called OnControl, Powered Biopsy 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.
Manual bone marrow sampling deviceDevice
Also called Jamshidi, Manual biopsy needle
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.
| Study group | Role | What they receive |
|---|---|---|
| Manual bone marrow sampling device | Active comparator | 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. Receives: Device: Manual bone marrow sampling device |
| OnControl Bone Marrow System | Active comparator | 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. Receives: Device: OnControl Bone Marrow Biopsy and Aspiration System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 during the needle insertion
Secondary outcomes (1)
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.
Measured: Day 1 needle insertion through needle removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2011 (estimated)
- Study startJan 2010
- Primary completionJul 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bone Marrow Biopsy ProceduresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vidacare Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Philbeck, PhD, Study director, Vidacare Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01312519
- Sponsor's protocol ID
- 2007-04
- Status last verified
- Jul 2013
- First submitted
- 3 Nov 2010
- Last updated
- 24 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial of the Vidacare Powered Bone Marrow Aspiration and Core Biopsy Systems (OnControl by Vidacare) Compared to Traditional Manual Devices
- ClinicalTrials.gov ID
- NCT01312519
- Acronym / sponsor ID
- 2007-04
- Conditions
- Bone Marrow Biopsy Procedures
- Keywords
- Bone marrow biopsy of iliac crest
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Vidacare CorporationIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 10 Mar 2011 (estimated)
- Results
- Posted 23 Jul 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual bone marrow sampling device | Active comparator | Device: Manual bone marrow sampling deviceHollow 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. |
| OnControl Bone Marrow System | Active comparator | Device: OnControl Bone Marrow Biopsy and Aspiration SystemBattery 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults over the age of 18
- Patients that require core biopsy alone, or core biopsy and bone marrow aspiration
Key exclusion criteria (5 listed)
- Imprisoned
- Pregnant
- Cognitively impaired
- Requiring english language translation other than Spanish
- Patients with one or more conditions precluding bone marrow core biopsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OnControl Bone Marrow Biopsy and Aspiration SystemAlso: OnControl, Powered Biopsy DeviceBattery 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. | Device | OnControl Bone Marrow System |
| Manual bone marrow sampling deviceAlso: Jamshidi, Manual biopsy needleHollow needle with a t-shaped handle that is pushed into the bone for the purpose of collecting bone marrow aspiration and core biopsy samples. | Device | Manual bone marrow sampling device |
Primary outcome
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.
1 secondary outcome
Time Necessary to Perform the Bone Marrow Procedure
Time frame: Day 1 needle insertion through needle removal
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Philbeck, PhD study director
Vidacare Corporation
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual bone marrow sampling device in people with Bone Marrow Biopsy Procedures, run by Vidacare Corporation at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subject Reported Level of Pain During Procedure (time frame: Day 1 during the needle insertion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.