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| Tracking Information | |||||
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| First Received Date ICMJE | October 12, 2007 | ||||
| Last Updated Date | March 13, 2009 | ||||
| Start Date ICMJE | August 2003 | ||||
| Estimated Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00544427 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Near Infrared Optical Coherence Tomography of the Upper Aero-Digestive Tract | ||||
| Official Title ICMJE | Near Infrared Optical Coherence Tomography of the Upper Aero-Digestive Tract | ||||
| Brief Summary | At Beckman Laser Institute, University of California, Irvine, we have developed diagnostic device call 'Optical Coherence tomography (OCT)'. OCT is an imaging technique capable of performing high-resolution,cross-sectional imaging. OCT enables real-time, in situ visualization of tissue microstructure without the need to excise and process the specimen as required for conventional biopsy and histopathology. Optical coherence tomography (OCT) is an emerging imaging modality that uses light to image turbid media such as living tissues, and has been successfully used to generate high resolution cross-sectional images of tissue microstructure in the human retina and skin. We have developed a multi-purpose OCT system for use in imaging the larynx, esophagus, trachea, oral cavity and nasal cavity with the overall objective of evaluating the efficacy of using OCT to image the microstructure of these organs. The OCT imaging system has image tissues of the aero-digestive tract during surgical endoscopy,the nose, oral cavity,larynx in an outpatient clinic setting. Knowledge of vocal cord, esophageal, tracheal, oral cavity, and nasal epithelial/mucosal microstructure would be extremely valuable in the treatment and diagnosis of both benign and malignant diseases of the upper aero-digestive tract, and at present there are no reliable techniques which provide this information with this degree of resolution other than a biopsy. |
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| Detailed Description | This study involves the collection of data through a noninvasive means in patients who are undergoing laryngeal, oral cavity, esophageal, tracheal, and nasal endoscopy for other medically indicated reasons. During laryngeal surgical endoscopy, the data obtained will not be used for patient care. Images will also be obtained using a surgical laryngoscope thru which an OCT imaging fiber is placed. The device focuses low power non-laser broad band infrared light onto laryngeal, esophageal, tracheal, oral and nasal tissue and does not involve input of significant amounts of energy into the subject; no temperature rise occurs. In this respect, it is quite similar to other diagnostic imaging techniques as well as other UCI IRB approved protocols (at least one of which is approved as expedited) involving near-infrared light. Because there is no direct contact of the device with the subject, and because the wavelength of light used for imaging does not have adverse tissue effects, there is no increase in risk over and above the risk the subject already accepts while undergoing general anesthesia or sedation. |
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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Case-Only, Prospective | ||||
| Condition ICMJE | Upper Areo-Digestive Tract | ||||
| Intervention ICMJE | Device: OCT | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||
| Estimated Enrollment ICMJE | 800 | ||||
| Estimated Completion Date | June 2012 | ||||
| Estimated Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | |||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00544427 | ||||
| Responsible Party | Brian JF Wong, M.D.,Ph.D, Beckman Laser Institute | ||||
| Study ID Numbers ICMJE | NIH OCT-EB-093-07, LAMMP MET RR-01192-29 | ||||
| Study Sponsor ICMJE | University of California, Irvine | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | University of California, Irvine | ||||
| Verification Date | March 2009 | ||||
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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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