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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01496287
Recruitment Status : Completed
First Posted : December 21, 2011
Results First Posted : July 24, 2014
Last Update Posted : November 6, 2014
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Otitis Media Device: Tube Delivery System (TDS) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tympanostomy Tube Placement in Children in the Office (Inova Study)
Study Start Date : December 2011
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Infections

Arm Intervention/treatment
Experimental: Tube placement group Device: Tube Delivery System (TDS)
Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system under local anesthesia in an office/clinic setting
Other Name: Tula TDS

Primary Outcome Measures :
  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 Outcome Measures :
  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.

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Ages Eligible for Study:   6 Months to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01496287

United States, Florida
South Coast Ear, Nose & Throat
Port St. Lucie, Florida, United States, 34952
Sponsors and Collaborators
Principal Investigator: Jacob W Zeiders, M.D. South Coast Ear, Nose & Throat