Barrow Nasal Inventory Survey (BNI)

This study is ongoing, but not recruiting participants.

Sponsor:

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

History of Changes

Tracking Information

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.

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Neurosurgery and endocrinology clinic

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

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:

Adults with planned endonasal surgery for pituitary tumor or skull base lesion

Exclusion Criteria:

Children

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

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

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

Principal Investigator:

Andrew Little, MD

Barrow Neurological Institute

Information Provided By

St. Joseph's Hospital and Medical Center, Phoenix

Verification Date

January 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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