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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00939796
Other study ID # CPR005005
Secondary ID
Status Completed
Phase N/A
First received July 14, 2009
Last updated September 26, 2014
Start date March 2009
Est. completion date July 2009

Study information

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

Clinical Trial Summary

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).


Recruitment information / eligibility

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

Study Design

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


Related Conditions & MeSH terms


Intervention

Device:
Acclarent Tympanostomy Tube Delivery System
A device which provides a means to create a myringotomy with insertion of a proloaded tympanostomy tube (TT) for placement of the TT in patients indicated for such treatment for Otitis Media

Locations

Country Name City State
United States Bay Area ENT Biloxi Mississippi
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 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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