Imaging Modality Effects on the Multi-dimensional InfraRed Analysis (MIRA) Technology
Recruitment status was Not yet recruiting
Tracking Information | |||||
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First Received Date ICMJE | December 9, 2009 | ||||
Last Updated Date | June 26, 2011 | ||||
Start Date ICMJE | August 2011 | ||||
Primary Completion Date | |||||
Current Primary Outcome Measures ICMJE | |||||
Original Primary Outcome Measures ICMJE | |||||
Change History | Complete list of historical versions of study NCT01029977 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE | |||||
Original Secondary Outcome Measures ICMJE | |||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Imaging Modality Effects on the Multi-dimensional InfraRed Analysis (MIRA) Technology | ||||
Official Title ICMJE | |||||
Brief Summary | The purpose of this study is to evaluate the effect of everyday practice modalities (mammography, US) on the MIRA technology. |
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Detailed Description | The objective of the current clinical study is to collect sufficient MIRA imaging data of subjects arriving for a routine screening mammography, before and after they undergo the mammography. This is in order to reach a conclusion whether the the firm breast compression involved in the mammography procedure affects the performance of the MIRA technology. At the current stage of the development of the device, the goal of this clinical trial is in no way to arrive at a statistical analysis. |
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Study Type ICMJE | Observational | ||||
Study Design ICMJE | Observational Model: Case-Only Time Perspective: Cross-Sectional |
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Biospecimen | |||||
Sampling Method | Non-Probability Sample | ||||
Study Population | Subjects arriving for a mammography or breast ultrasound |
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Condition ICMJE | Breast Cancer | ||||
Intervention ICMJE | |||||
Study Group/Cohort (s) | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Not yet recruiting | ||||
Estimated Enrollment ICMJE | 50 | ||||
Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Female | ||||
Ages | 50 Years and older | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts ICMJE |
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Location Countries ICMJE | Israel | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT01029977 | ||||
Other Study ID Numbers ICMJE | 960-PRL-002 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Mr. Boaz Arnon, CEO, Real Imaging Ltd. | ||||
Study Sponsor ICMJE | Real Imaging Ltd. | ||||
Collaborators ICMJE | |||||
Investigators ICMJE | |||||
Information Provided By | Real Imaging Ltd. | ||||
Verification Date | December 2009 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |