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Completed

NCT Number: NCT01496287

Tympanostomy Tube Placement in Children in the Office (Inova Study)

The objective of the study is to evaluate the safety and efficacy of the Acclarent Tula TDS for the placement of tympanostomy tubes 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–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

South Coast Ear, Nose & Throat

Port Saint Lucie, Florida, 34952, 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 and younger than 22 years old
  • Behavioral capacity and cooperative temperament to undergo an awake procedure (based on physician judgement)
  • No history of sensitivity or reaction to anesthesia chosen for the procedure

Exclusion criteria

  • Pregnant or lactating females
  • Significantly atrophic, bimeric, or completely atelectatic tympanic membrane
  • Otitis externa
  • Lacerations or abrasions to the external auditory canal or damaged or denuded skin in the auditory canal
  • Cerumen impaction resulting in a significant amount of cleaning required to visualize the tympanic membrane
  • Electrically sensitive subjects and subjects with electrically sensitive support systems (pacemakers, defibrillators, etc.)
  • 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

Tube Delivery System (TDS)

Device

Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system under local anesthesia in an office/clinic setting

Other names: Tula TDS

Primary outcomes

  1. Number of Participants With Procedural, Serious, and Device-Related Adverse Events

    Time frame: procedure up to 2 weeks post procedure

    Adverse events which are procedural, serious, and device-related.

  2. Device Success

    Time frame: Day 0 (day of procedure)

    Device Success is defined as the successful delivery of the tympanostomy tube (TT) across the tympanic membrane (TM) using the Tube Delivery System(TDS). Device Success will be evaluated on a per device basis.

Secondary outcomes

  1. Procedure Success

    Time frame: Day 0 (day of procedure)

    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.

  2. Procedure Tolerability

    Time frame: Day 0 (day of procedure)

    Procedure Tolerability is defined as the proportion of subjects reporting the procedure as tolerable, where tolerable is defined as a score of 0 through 3, using the Wong-Baker FACES pain scale.The Wong-Baker FACES pain scoring system is a scale of 0 to 5, where 0 means 'no hurt', 1 = 'hurts a little bit', 2 = 'hurts little more', 3 = 'hurts even more', 4 = 'hurts whole lot' and 5 = 'hurts worst'. Procedure Tolerability will be determined on a per patient basis, with the patient's score being the average of the scores for the left and right ear if both ears are successfully treated with the Tube Delivery System.

    "Tolerability" was defined as an average post-procedure pain score (of treated ears) <= "3"

  3. Tube Retention

    Time frame: 2 weeks post procedure

    Tube retention is the presence of a tympanostomy tube placed successfully by the Tula TDS device across the tympanic membrane at the two-week follow-up visit.

Sponsors and collaborators

Lead sponsor

Integra LifeSciences Corporation

Industry

Collaborators

  • Acclarent

Registry information

Acronym: Inova

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 21, 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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