Expired Study
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Rochester, Minnesota 55904


Purpose:

Empty Nose Syndrome patients suffer from disabling physical symptoms and considerable distress. To date there is no definitive cure for these symptoms. Established treatment modalities include saline irrigation, surgical implantation of materials or simply use of cotton wads/ silicon cones to simulate the resistive action to airflow of the resected turbinates. With this study, we will determine the effectiveness of a new treatment modality in the treatment of Empty Nose Syndrome. This novel treatment method involves the use of Botox.


Study summary:

Background: Empty Nose Syndrome (ENS) is the term used to describe the condition resulting from over resection of nasal turbinate. Symptoms include depression, dysosmia, bleeding, discharge, crusting, dryness, dysosmia, and pain. Treatment modalities include adjunctive comfort measures (primarily irrigation), mechanical measures (Silicon cones, cotton wads) and surgical treatment (alloderm implants, plasti-pore cartilage grafts etc.) We will investigate a new method of treatment for ENS. This will involve injection of Botox Type A into the dilator nasalis muscle thus collapsing the internal nasal valve to provide added resistance to air flow. Objective: To evaluate effectiveness of Botox in improving overall QoL in patients. Methods: 42 subjects will undergo treatment with Botox and adjunctive measures that will involve the use of saline irrigation alongwith sesame oil amongst other measures. Before and after treatment data will be obtained in the form of a breathing test and patient questionnaires that will help us measure changes in physical and mental health (using the sinonasal outcome test questionnaire or SNOT 22, the short form health survey 36 item questionnaire, and the Impact of events revised scale). Conclusion: We anticipate that Botox application in ENS patients improve overall QoL in these subjects.


Criteria:

Inclusion Criteria: - Any patient aged 18-65 years of age presenting with a known diagnosis of ENS who has no known allergies to Botox. Exclusion Criteria: - Patients younger than 18 years or older than 65 years of age. - Patients with neuromuscular disorders or neuropathic diseases. - Patients with infection and or swelling at the site where Botox is to be injected. - Patients with known hypersensitivity to any ingredient in the drug formulation (botulinum toxin, human albumin) - Patients who are or plan to become pregnant within the time period in which the study will be conducted. - Patients who are nursing


NCT ID:

NCT00732680


Primary Contact:

Principal Investigator
Oren Friedman, M.D.
Mayo Clinic


Backup Contact:

N/A


Location Contact:

Rochester, Minnesota 55904
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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