Simultaneous Fluoroscopic and Endoscopic Examination of the Oropharyngeal Phase of Deglutition
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| First Received Date ICMJE | December 26, 2007 | ||||
| Last Updated Date | December 16, 2010 | ||||
| Start Date ICMJE | March 2007 | ||||
| Primary Completion Date | June 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00584623 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 | Simultaneous Fluoroscopic and Endoscopic Examination of the Oropharyngeal Phase of Deglutition | ||||
| Official Title ICMJE | Simultaneous Fluoroscopic and Endoscopic Examination of the Oropharyngeal Phase of Deglutition | ||||
| Brief Summary | To correlate findings between two commonly-used types of swallowing studies: videofluoroscopy and flexible endoscopic evaluation of swallowing (FEES). |
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| Detailed Description | The specific aim of this study is to correlate findings between two commonly-used types of swallowing studies: videofluoroscopy and flexible endoscopic evaluation of swallowing (FEES). Specifically, the timing of swallowing events will be correlated between teh two studies. In addition, the pharyngeal constriction ratio (a validated measure of pharyngeal strength on videofluoroscopy) will be compared with the pharyngeal squeeze maneuver (an assessment of pharyngeal strength on FEES), with the hypothesis that there will be a strong correlation between PCR and pharyngeal squeeze. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Adult clinic population in the UCD Otolaryngology Clinic |
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| Condition ICMJE | Dysphagia | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| 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 | Completed | ||||
| Enrollment ICMJE | 0 | ||||
| Completion Date | June 2008 | ||||
| Primary Completion Date | June 2008 (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 | NCT00584623 | ||||
| Other Study ID Numbers ICMJE | 200715188-1 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Peter C. Belafsky, MD, Ph.D., University of California Davis | ||||
| Study Sponsor ICMJE | University of California, Davis | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of California, Davis | ||||
| Verification Date | December 2010 | ||||
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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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