inVENT-In-Office Study

Otitis Media Clinical Trial

— inVENT-IO  

Official title:

A Clinical Study Of The Acclarent Tympanostomy Tube (Tula™) Delivery System In-Office

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01324271
• Other study ID #: CPR005016
• Status: Completed
• Phase: N/A
• First received: March 23, 2011
• Last updated: December 8, 2014
• Start date: January 2011
• Est. completion date: May 2012

Study information

• Verified date: December 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 the study is to evaluate the safety and efficacy of the Acclarent Tympanostomy Tube Delivery System (TTDS) for the placement of tympanostomy tubes (TT) under local anesthesia in an office/clinic setting.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months and older

Eligibility

Inclusion Criteria:

• Scheduled to undergo tympanostomy tube insertion

• At least 6 months old

• Behavioral capacity and cooperative temperament to undergo an awake procedure (based on physician judgement)

Exclusion Criteria:

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

• Significantly atrophic, bimeric, or completely atelectatic tympanic membrane

• Otitis externa

• 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 Media

Intervention

Device:
• Acclarent Tympanostomy Tube Delivery system (TTDS)
placement of tympanostomy tube under local anesthesia

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	Percentage of Subjects With In-office Tube Placement Procedure Success	Procedure Success is defined as the successful placement of any tympanostomy tube in all enrolled ears in a given subject. Procedure Success is determined on a per subject basis: the rate was calculated based on the number of subjects achieving Procedure Success out of the total number of enrolled subjects. Only subjects for whom tubes were placed under local anesthesia were evaluated for Procedure Success.	Day 0	No
Primary	Percentage of Tubes Successfully Placed Using a TTDS Device	Device (TTDS) success is defined as the successful delivery of a pre-loaded TT tube across the tympanic membrane using the TTDS. Device success will be evaluated per device attempted. Office/clinical subjects only.; A Device (Type of Unit analyzed) is defined as a TDS attempt. This is not synonymous with "tube." Tube is the outcome of the device use.	Day 0	No
Secondary	Number of Retained (TTDS-placed) Tubes	Tube retention is the presence of a TT placed successfully by the TTDS device across the tympanic membrane at the two week follow-up visit. Tube retention was confirmed by physician investigator evaluation. N=74 tubes were successfully placed intraprocedurally. Analysis population includes office/clinical subjects only.	14 days	No