Acclarent Tympanostomy Tube Delivery System for the Treatment of Patients Requiring Tympanostomy Tube Insertion

Otitis Media Clinical Trial

— inVENT2  

Official title:

A Clinical Study of the Acclarent Tympanostomy Tube Delivery System for the Treatment of Patients Requiring Tympanostomy Tube Insertion for Otitis Media

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02150044
• Other study ID #: CPR005008
• Status: Completed
• Phase: N/A
• First received: May 27, 2014
• Last updated: September 25, 2014
• Start date: February 2010
• Est. completion date: November 2010

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

This was a non-significant risk (NSR), prospective, multi-center, single arm clinical trial that aimed to evaluate safety and performance of the Acclarent Tympanostomy Tube Delivery System (TTDS).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: November 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Diagnosed with either chronic otitis media with effusion (OME) or recurrent acute otitis media (AOM) and scheduled to undergo tympanostomy tube insertion

Exclusion Criteria:

• History of sensitivity or reaction to anesthesia chosen for the procedure

• Markedly atrophic, mono- or 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 sufficient visualization of and access to the tympanic membrane

• Anatomy that necessitates tympanostomy tube placement in the posterior half of the tympanic membrane

Study Design

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

Related Conditions & MeSH terms

• Otitis
• Otitis Media

Intervention

Device:
• Acclarent Tympanostomy Tube Delivery System (TTDS).
tympanostomy tube delivery system

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Acclarent

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ear Outcome Success	Ear Outcome Success is successful delivery of the tympanostomy tube (TT) across the tympanic membrane (TM) per ear. This endpoint was evaluated for the 13 study cohort subjects only (not the 16 lead-in subjects).	Day 0 (at procedure visit)	Yes
Secondary	Procedure Success	Procedure Success is the successful placement of any tympanostomy tube evaluated on a per subject basis. This endpoint was evaluated for the 13 study cohort subjects only (not the 16 lead-in subjects).	Day 0 (at procedure visit)	Yes
Secondary	Tube Retention	Tube Retention is the presence of a TTDS-placed tympanostomy tube across the tympanic membrane (TM) at the Follow-Up visit evaluated by ear. This endpoint was evaluated for the 13 study cohort subjects only (not the 16 lead-in subjects).	1 week	No