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Completed

NCT Number: NCT01324271

inVENT-In-Office Study

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.

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Key information

Conditions

Otitis Media Ear Diseases Otitis Otorhinolaryngologic Diseases

Age range

6 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Antonio, Texas, 78240, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acclarent Tympanostomy Tube Delivery system (TTDS)

Device

placement of tympanostomy tube under local anesthesia

Other names: Tula™

Primary outcomes

  1. Percentage of Subjects With In-office Tube Placement Procedure Success

    Time frame: 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.

  2. Percentage of Tubes Successfully Placed Using a TTDS Device

    Time frame: 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 outcomes

  1. Number of Retained (TTDS-placed) Tubes

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Integra LifeSciences Corporation

Industry

Collaborators

  • Acclarent

Registry information

Official study title

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

Acronym: inVENT-IO

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 29, 2011
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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