Clinical Study of the Tympanostomy Tube Delivery System

Not Applicable

Completed

• Conditions: Otitis Media With Effusion
• Interventions: Device: Acclarent Tympanostomy Tube Delivery System

• Registration Number: NCT00939796
• Lead Sponsor: Integra LifeSciences Corporation

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Primary Completion: 2009-06
• Study Completion: 2009-07
• Study First Submitted: 2009-07-14
• Study First Submitted QC: 2009-07-14
• Study First Posted: 2009-07-15
• Results First Submitted: 2014-05-07
• Results First Submitted QC: 2014-05-07
• Results First Posted: 2014-06-09
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-10
• Last Update Posted: 2024-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tympanostomy Tube Delivery System (TTDS)	Acclarent Tympanostomy Tube Delivery System	Tympanostomy tube placement with Acclarent tube delivery system

Primary Outcome Measures

Name	Time	Method
Device Success	At procedure visit	Successful deployment of the tube in each indicated ear using the TTDS. Evaluated for test cohort subjects only (not lead-in subjects).

Secondary Outcome Measures

Name	Time	Method
Tube Retention	two weeks post-procedure	Presence of the Tympanostomy Tube across the tympanic membrane at two weeks post-procedure. Evaluated for test cohort subjects only (not lead-in subjects).
Cross-Over to Manual Myringotomy and Tube Placement	at procedure visit	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.

Trial Locations

Locations (2)

Bay Area ENT; 🇺🇸 Biloxi, Mississippi, United States

Ear Medical Group; 🇺🇸 San Antonio, Texas, United States