Bone Marrow BiopsyNCT01535313
Comparison of a Powered Bone Marrow Biopsy Device With a Manual System
A study of Bone Marrow Biopsy, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Bone marrow biopsy quality as quantified by biopsy cylinder length and diagnostic usefulness is improved with a powered bone marrow biopsy device in comparison with a manual device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Marrow Biopsy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2011to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- age > 18
- >= one previous bone marrow procedure
- INR > 1.4
- tThrombocyte count > 10 x109/l
- informed consent signed
Who cannot join
- cognitive impairment
- excessive tissue at anatomical landmarks
- BMI > 35 kg/m2
- allergy to premedication
- unable to lay flat in prone position
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel
Basel, Canton of Basel-City, 4032
About this study
Official title: a Prospective Randomized Controlled Trial Comparing a Powered Bone Marrow Biopsy Device With a Manual System
Bone marrow biopsy quality as quantified by biopsy cylinder length and diagnostic usefulness is improved with a powered bone marrow biopsy device in comparison with a manual device.
- Conditions
- Bone Marrow Biopsy
- Being tested
- OnControl BM-Biopsy system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OnControl BM-Biopsy systemDevice
Also called http://www.vidacare.com/OnControl/Bone-Marrow-Clinicians.aspx, http://www.hsmedicalinc.com/
Bone marrow biopsy at posterior iliac crest
| Study group | Role | What they receive |
|---|---|---|
| Manual (Hospital Systems TRAP Needle) | Active comparator | Bone marrow biopsy with a standard manual system Receives: Device: OnControl BM-Biopsy system |
| Powered | Experimental | Not described Receives: Device: OnControl BM-Biopsy system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic usefulness (yes/no) of biopsy cylinder
The bone marrow biopsy cylinder is assessed by a pathologist who rates either "diagnostic" or "non diagnostic"
Measured: within 1 week of biopsy
Secondary outcomes (1)
patient pain during procedure
patients underdoing biopsy rate the pain during, 15 min after and 3-5 days after the proceedure
Measured: day 1 (two time points) and day 3-5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2012 (estimated)
- Study startMay 2011
- Primary completionSep 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Marrow BiopsyStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christoph M Bucher, MD, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01535313
- Sponsor's protocol ID
- Biopsycontrol
- Status last verified
- Feb 2012
- First submitted
- 9 Feb 2012
- Last updated
- 17 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- a Prospective Randomized Controlled Trial Comparing a Powered Bone Marrow Biopsy Device With a Manual System
- ClinicalTrials.gov ID
- NCT01535313
- Acronym / sponsor ID
- Biopsycontrol
- Conditions
- Bone Marrow Biopsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 17 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Bone marrow biopsy quality as quantified by biopsy cylinder length and diagnostic usefulness is improved with a powered bone marrow biopsy device in comparison with a manual device.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual (Hospital Systems TRAP Needle) | Active comparator | Device: OnControl BM-Biopsy systemBone marrow biopsy with a standard manual system |
| Powered | Experimental | Device: OnControl BM-Biopsy system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age > 18
- >= one previous bone marrow procedure
- INR > 1.4
- tThrombocyte count > 10 x109/l
- informed consent signed
Key exclusion criteria (5 listed)
- cognitive impairment
- excessive tissue at anatomical landmarks
- BMI > 35 kg/m2
- allergy to premedication
- unable to lay flat in prone position
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 BM-Biopsy systemAlso: http://www.vidacare.com/OnControl/Bone-Marrow-Clinicians.aspx, http://www.hsmedicalinc.com/Bone marrow biopsy at posterior iliac crest | Device | Manual (Hospital Systems TRAP Needle), Powered |
Primary outcome
Diagnostic usefulness (yes/no) of biopsy cylinder
Time frame: within 1 week of biopsy
The bone marrow biopsy cylinder is assessed by a pathologist who rates either "diagnostic" or "non diagnostic"
1 secondary outcome
patient pain during procedure
Time frame: day 1 (two time points) and day 3-5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2012.
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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.
Christoph M Bucher, MD principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Bone Marrow Biopsy, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 5 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 17 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Diagnostic usefulness (yes/no) of biopsy cylinder (time frame: within 1 week of biopsy). 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 17 Feb 2012.