Acute Otitis Media Clinical Trial
— inVENT-OROfficial title:
A Clinical Study of the Acclarent Tympanostomy Tube Delivery System for the Treatment of Patients Requiring Tympanostomy Tube Insertion for Otitis Media
Verified date | June 2014 |
Source | Acclarent |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
The purpose of this study is to evaluate the performance and safety of the Tympanostomy Tube Delivery System (TTDS) for chronic otitis media or recurrent acute otitis media.
Status | Completed |
Enrollment | 53 |
Est. completion date | December 2010 |
Est. primary completion date | November 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 6 Months and older |
Eligibility |
Inclusion Criteria: - Diagnosed with either chronic otitis media with effusion or acute otitis media and scheduled to undergo tympanostomy tube insertion Exclusion Criteria: - Reaction to anesthesia - Markedly atrophic, bimeric, severely retracted, atelectatic or perforated tympanic membrane - Otitis externa - Active acute otitis media - Otitis media pathology requiring T-tubes - Stenosed ear canal - Anatomy that precludes visualization and access to tympanic membrane - Anatomy that necessitates tympanostomy tube placement in posterior half of membrane |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Evergreen Sinus Center | Kirkland | Washington |
United States | Advanced ENT and Allergy | Louisville | Kentucky |
United States | South Coast ENT | Port St. Lucie | Florida |
United States | Ear Medical Group | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
Acclarent |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety of Tympanostomy Tube (TT) Delivery System | Occurrence of pre-defined Safety Events of acoustic trauma, deployment of the TT into the middle ear, damage to middle ear structures, unintended tympanic membrane perforation requiring treatment, abrasion to the external acoustic meatus requiring significant treatment, and major bleeding requiring significant treatment. | 7 days | Yes |
Primary | Device Success | Device Success is defined as the successful delivery of the tympanostomy tube across the tympanic membrane using the tympanostomy tube delivery system (TTDS).Device Success is evaluated on a per device basis. | 0 days | No |
Secondary | Proportion of Subjects With Procedure Success | Procedure Success was defined as the successful placement of any tympanostomy tube in all enrolled ears in a given subject. Non-Acclarent tubes successfully placed manually following non-success of the TTDS were counted toward Procedure Success. Procedure Success was determined on a per subject basis: the rate was calculated by the number of subjects achieving Procedure Success out of the total number of enrolled subjects. | 0 days | No |
Secondary | Tube Retention | Presence of the tympanostomy tube across the tympanic membrane at the follow-up visit. | 7 days | No |
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