Optical Coherence Tomography of Airway and Pleural Disorders
| Tracking Information | |||||
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| First Received Date ICMJE | December 20, 2007 | ||||
| Last Updated Date | December 26, 2012 | ||||
| Start Date ICMJE | July 2007 | ||||
| Estimated Primary Completion Date | July 2015 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Screening aid in identification of suspect tissue lesion. [ Time Frame: 30 MINUTES ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00580892 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Optical Coherence Tomography of Airway and Pleural Disorders | ||||
| Official Title ICMJE | Optical Coherence Tomography of Airway and Pleural Disorders | ||||
| Brief Summary | Endobronchial disorders represent abnormal processes within the network of passages delivering air to the lung, including lung cancers. Pleural disorders involve the membrane that covers the lung and lines the inside of the chest walls. Early detection of these disorders is essential to timely, accurate diagnosis and treatment of these conditions including cancer, inflammation and infections. |
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| Detailed Description | Optical methods for obtaining images in airway passages for early detection of endobronchial lung and pleural cancer are needed. Optical coherence tomography (OCT) is a non-invasive or minimally invasive diagnostic technique that can provide information about tissue abnormalities. OCT can produce images of abnormalities both at and below the surface of the airways without damaging the tissue surface This technique uses a harmless device to emit infrared (not visible) light that can produce images of the specimen under investigation without causing damage or alterations. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | primary care clinic |
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| Condition ICMJE | Endobronchial Disorder | ||||
| Intervention ICMJE | Device: OCT
imaging |
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| Study Group/Cohort (s) | diagnostic
imaging
Intervention: Device: OCT |
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| Publications * | Not Provided | ||||
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* 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 | Enrolling by invitation | ||||
| Estimated Enrollment ICMJE | 150 | ||||
| Estimated Completion Date | July 2015 | ||||
| Estimated Primary Completion Date | July 2015 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00580892 | ||||
| Other Study ID Numbers ICMJE | NIH OCT. EB-093-07 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Montana Compton, University of California, Irvine | ||||
| Study Sponsor ICMJE | Montana Compton | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of California, Irvine | ||||
| Verification Date | December 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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