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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01202578
Other study ID # CPR005013
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received September 13, 2010
Last updated June 10, 2014
Start date September 2010
Est. completion date December 2010

Study information

Verified date June 2014
Source Acclarent
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Device:
tympanostomy tube
tympanostomy tube delivery system

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Acclarent

Country where clinical trial is conducted

United States, 

Outcome

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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