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Completed

NCT Number: NCT02150044

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

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).

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Key information

Conditions

Otitis Media Ear Diseases Otitis Otorhinolaryngologic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kirkland, Washington, 98034, United States

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Acclarent Tympanostomy Tube Delivery System (TTDS).

Device

tympanostomy tube delivery system

Primary outcomes

  1. Ear Outcome Success

    Time frame: Day 0 (at procedure visit)

    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).

Secondary outcomes

  1. Procedure Success

    Time frame: Day 0 (at procedure visit)

    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).

  2. Tube Retention

    Time frame: 1 week

    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).

Sponsors and collaborators

Lead sponsor

Integra LifeSciences Corporation

Industry

Collaborators

  • Acclarent

Registry information

Official study title

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

Acronym: inVENT2

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
May 29, 2014
Registry last updated
Jul 12, 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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