Otitis Media With Effusion Clinical Trial
— inVENTOfficial title:
A Clinical Study of the Acclarent Tympanostomy Tube Delivery System For the Treatment of Patients Requiring Tympanostomy Tube Insertion for Otitis Media (inVENT)
Verified date | September 2014 |
Source | Acclarent |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
The objective of this investigational study is to evaluate the safety and performance of the Acclarent Tympanostomy Tube Delivery System (TTDS) for the placement of the Tympanostomy Tube [TT(s)] in patients indicated for such treatment for chronic otitis media with effusion (OME) or recurrent acute otitis media (AOM).
Status | Completed |
Enrollment | 16 |
Est. completion date | July 2009 |
Est. primary completion date | June 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: 1. Patients scheduled to undergo bilateral or unilateral tympanostomy tube insertion. 2. Either male or female Exclusion Criteria: 1. History of sensitivity or reaction to anesthesia chosen for the procedure 2. Markedly atrophic, mono- or bimeric, severely retracted, atelectatic or perforated tympanic membrane 3. Otitis externa 4. Active acute otitis media 5. Otitis media pathology 6. Stenosed ear canal |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Bay Area ENT | Biloxi | Mississippi |
United States | Ear Medical Group | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
Acclarent |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Device Success | Successful deployment of the tube in each indicated ear using the TTDS. Evaluated for test cohort subjects only (not lead-in subjects). | At procedure visit | No |
Secondary | Cross-Over to Manual Myringotomy and Tube Placement | Conversion of the procedure from Tympanostomy Tube Delivery System to manual myringotomy and tube placement. Evaluated for test cohort subjects only (not lead-in subjects). Decision to convert to a manual myringotomy and tube placement procedure occurs at the conclusion of the Tube Delivery System procedure. | at procedure visit | No |
Secondary | Tube Retention | Presence of the Tympanostomy Tube across the tympanic membrane at two weeks post-procedure. Evaluated for test cohort subjects only (not lead-in subjects). | two weeks post-procedure | No |
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