Barrow Nasal Inventory Survey (BNI)
This study is ongoing, but not recruiting participants.
Sponsor:
St. Joseph's Hospital and Medical Center, Phoenix
Information provided by (Responsible Party):
St. Joseph's Hospital and Medical Center, Phoenix
ClinicalTrials.gov Identifier:
NCT01322945
First received: March 23, 2011
Last updated: January 4, 2012
Last verified: January 2012
| Tracking Information | |||||
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| First Received Date ICMJE | March 23, 2011 | ||||
| Last Updated Date | January 4, 2012 | ||||
| Start Date ICMJE | January 2011 | ||||
| Estimated Primary Completion Date | January 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Patient perception of change in nasal functioning [ Time Frame: 90 days ] [ Designated as safety issue: No ] A survery asking patients about the functioning of their nose will be administered to patients before endonasal surgery and ninety days after to determine if there is a change in functioning. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01322945 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 | Barrow Nasal Inventory Survey | ||||
| Official Title ICMJE | Observational Study of Nasal Outcomes Following Endonasal Surgery for Anterior Skull Base Lesions | ||||
| Brief Summary | The purpose of this study is to evaluate patient nasal outcome following endo-nasal surgery. This type of surgery is conducted for pituitary and skull base tumors. There is no published data on trauma to the nose during surgery and how it impacts nasal functioning. The investigators propose to develop a survey and administer it to patients before and after surgery to learn about their perception of nasal functioning. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Neurosurgery and endocrinology clinic |
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| Condition ICMJE | Pituitary Tumors | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Enodnasal surgery, pituitary tumor, nasal functioning
Single cohort of patients undergoing endonasal surgery |
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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 | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Completion Date | Not Provided | ||||
| Estimated Primary Completion Date | January 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 80 Years | ||||
| 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 | NCT01322945 | ||||
| Other Study ID Numbers ICMJE | 10BN172 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | St. Joseph's Hospital and Medical Center, Phoenix | ||||
| Study Sponsor ICMJE | St. Joseph's Hospital and Medical Center, Phoenix | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | St. Joseph's Hospital and Medical Center, Phoenix | ||||
| Verification Date | January 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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