MammographyNCT00724516
Evaluation Of A Novel Breast Compression Paddle For Wire Localization In Mammography
A study testing Novel Breast Compression Paddle in people with Mammography and Biopsy, Needle, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the functionality of a new breast compression paddle used in mammography for wire localization. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Mammography, Biopsy, Needle
- What is being tested?
- Novel Breast Compression Paddle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Dec 2010
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women who are scheduled to undergo a wire localization procedure on the digital mammography unit at the University of Michigan Cancer Center
Who cannot join
- Men
- Pregnant Women
- Lactating Women
- Prisoners
- Children under the age of 18
- Mentally impaired individuals
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Health System
Ann Arbor, Michigan, 48109
About this study
The purpose of this study is to evaluate the functionality of a new breast compression paddle used in mammography for wire localization.
Read the detailed description
Presently, the breast compression paddles that are used in mammography for wire localization are made of plastic and contain a relatively small rectangular shaped opening through which the wire is placed in the breast. When technologists use this paddle, they must carefully position the breast such that the rectangular opening is above the region for wire localization. A novel paddle has been developed which increases the wire localization access area tremendously and should therefore make it easier to perform the procedure. The purpose of this study is to evaluate the functionality of this new compression paddle. The new compression paddle was developed by Biomedical Engineering students in conjunction with Radiologists and a Medical Physicist at the University of Michigan. It was designed and manufactured for a student project in the Mechanical Engineering 450/599 course at the University of Michigan.
- Conditions
- Mammography, Biopsy, Needle
- Being tested
- Novel Breast Compression Paddle
- Keywords
- Mammogram, Biopsy, Needle, Wire, Localization, Compression, Paddle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel Breast Compression PaddleDevice
Instead of using the regular wire localization mammography compression paddle, a new breast compression paddle will be used. The new breast compression paddle is similar to a tennis racquet. It consists of crossing plastic strings that are strung tightly in a frame. The needle/wire can be inserted anywhere between the strings.
| Study group | Role | What they receive |
|---|---|---|
| Novel Breast Compression Paddle | Experimental | Women scheduled to undergo a breast mammography wire localization procedure will have a new breast compression paddle will be used Instead of using the regular wire localization mammography compression paddle. Receives: Device: Novel Breast Compression Paddle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the newly designed breast compression paddle.
To objectively determine if the functionality of this new breast compression paddle allows for easier access to the breast during wire localization.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2008 (estimated)
- Study startJun 2007
- Primary completionDec 2009
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MammographyStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caroline Blane, University of Michigan
- Investigators
- Caroline Blane, M.D., Principal investigator, University of Michigan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00724516
- Sponsor's protocol ID
- HUM00013441
- Status last verified
- Jul 2017
- First submitted
- 23 Jul 2008
- Last updated
- 6 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of A Novel Breast Compression Paddle For Wire Localization In Mammography
- ClinicalTrials.gov ID
- NCT00724516
- Acronym / sponsor ID
- HUM00013441
- Conditions
- Mammography, Biopsy, Needle
- Keywords
- Mammogram, Biopsy, Needle, Wire, Localization, Compression, Paddle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 29 Jul 2008 (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.
The purpose of this study is to evaluate the functionality of a new breast compression paddle used in mammography for wire localization.
Detailed description
Presently, the breast compression paddles that are used in mammography for wire localization are made of plastic and contain a relatively small rectangular shaped opening through which the wire is placed in the breast. When technologists use this paddle, they must carefully position the breast such that the rectangular opening is above the region for wire localization. A novel paddle has been developed which increases the wire localization access area tremendously and should therefore make it easier to perform the procedure. The purpose of this study is to evaluate the functionality of this new compression paddle. The new compression paddle was developed by Biomedical Engineering students in conjunction with Radiologists and a Medical Physicist at the University of Michigan. It was designed and manufactured for a student project in the Mechanical Engineering 450/599 course at the University of Michigan.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Novel Breast Compression Paddle | Experimental | Device: Novel Breast Compression PaddleWomen scheduled to undergo a breast mammography wire localization procedure will have a new breast compression paddle will be used Instead of using the regular wire localization mammography compression paddle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women who are scheduled to undergo a wire localization procedure on the digital mammography unit at the University of Michigan Cancer Center
Key exclusion criteria (6 listed)
- Men
- Pregnant Women
- Lactating Women
- Prisoners
- Children under the age of 18
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 |
|---|---|---|
| Novel Breast Compression PaddleInstead of using the regular wire localization mammography compression paddle, a new breast compression paddle will be used. The new breast compression paddle is similar to a tennis racquet. It consists of crossing plastic strings that are strung tightly in a frame. The needle/wire can be inserted anywhere between the strings. | Device | Novel Breast Compression Paddle |
Primary outcome
Evaluate the newly designed breast compression paddle.
Time frame: 1 year
To objectively determine if the functionality of this new breast compression paddle allows for easier access to the breast during wire localization.
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 6 Jul 2017.
- Individual participant dataSharing planned: No
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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.
Caroline Blane, M.D. principal investigator
University of Michigan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novel Breast Compression Paddle in people with Mammography and Biopsy, Needle, run by University of Michigan at 1 site in United States.
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 1 inclusion and 6 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 6 Jul 2017. 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 United States. 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?
Evaluate the newly designed breast compression paddle. (time frame: 1 year). 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 6 Jul 2017.