Automated Tube Deployment: Success Demonstrated in OR

Autor:	Charles A. Syms, Jacob W. Zeiders, Kenneth D. Faw, Andrew R. Gould
Rok vydání:	2011
Předmět:	medicine.medical_specialty medicine.diagnostic_test business.industry medicine.medical_treatment Physical examination Surgery Myringotomy Otitis Otorhinolaryngology Effusion medicine Tube (fluid conveyance) Tympanostomy tube medicine.symptom Audiometry business Adverse effect
Zdroj:	Otolaryngology–Head and Neck Surgery. 145
ISSN:	1097-6817 0194-5998
Popis:	Objective: Investigate the safety and efficacy of a novel automated tympanostomy tube delivery system for the creation of a myringotomy and the placement of a tympanostomy tube for patients presenting with chronic otitis media with effusion and/or recurrent acute otitis media.Method: A prospective, multicenter, single arm clinical study enrolled 53 subjects. Tube placement was performed in an operative setting using the Acclarent Tympanostomy Tube Delivery System (TTDS). Patients underwent physical examination and audiometry preoperatively and at one week postoperatively.Results: A total of 53 subjects (47 subjects 5 years of age and younger) were enrolled in the study at 4 United States centers. From these subjects, 101 ears were enrolled and 5 were excluded because of study criteria related to condition of the tympanic membrane. There were no serious device-related adverse events. The primary efficacy endpoint, successful tube deployment across the tympanic membrane, was achieved: 95 of 101 (94%) attemp...
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_________::e1b7b8c5d4cb6ff130273c48e7e68545 https://doi.org/10.1177/0194599811416318a34 Zobrazit plný text záznamu Plný text