inVENT-In-Office Study

Not Applicable

Completed

• Conditions: Otitis Media
• Interventions: Device: Acclarent Tympanostomy Tube Delivery system (TTDS)

• Registration Number: NCT01324271
• Lead Sponsor: Integra LifeSciences Corporation

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-03-23
• Study First Submitted QC: 2011-03-28
• Study First Posted: 2011-03-29
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Results First Submitted: 2014-06-01
• Results First Submitted QC: 2014-11-18
• Results First Posted: 2014-11-25
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-10
• Last Update Posted: 2024-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tympanostomy tube placement	Acclarent Tympanostomy Tube Delivery system (TTDS)	placement of tympanostomy tube under local anesthesia in office/clinic setting

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects With In-office Tube Placement Procedure Success	Day 0	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.
Percentage of Tubes Successfully Placed Using a TTDS Device	Day 0	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.

Secondary Outcome Measures

Name	Time	Method
Number of Retained (TTDS-placed) Tubes	14 days	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.