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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2012-04-30

Brief Summary

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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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Detailed Description

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Conditions

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Otitis Media

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tube placement group

Group Type EXPERIMENTAL

Tube Delivery System (TDS)

Intervention Type DEVICE

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

Interventions

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Tube Delivery System (TDS)

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

Intervention Type DEVICE

Other Intervention Names

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Tula TDS

Eligibility Criteria

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Inclusion Criteria

1. Scheduled to undergo tympanostomy tube insertion
2. At least 6 months old and younger than 22 years old
3. Behavioral capacity and cooperative temperament to undergo an awake procedure (based on physician judgement)
4. No history of sensitivity or reaction to anesthesia chosen for the procedure

Exclusion Criteria

1. Pregnant or lactating females
2. Significantly atrophic, bimeric, or completely atelectatic tympanic membrane
3. Otitis externa
4. Lacerations or abrasions to the external auditory canal or damaged or denuded skin in the auditory canal
5. Cerumen impaction resulting in a significant amount of cleaning required to visualize the tympanic membrane
6. Electrically sensitive subjects and subjects with electrically sensitive support systems (pacemakers, defibrillators, etc.)
7. Anatomy that precludes sufficient visualization of and access to the tympanic membrane
8. Anatomy that necessitates tympanostomy tube placement in the posterior half of the tympanic membrane

Minimum Eligible Age

6 Months

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No