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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Acclarent
ClinicalTrials.gov Identifier:
NCT01496287
First received: December 16, 2011
Last updated: June 26, 2014
Last verified: June 2014
  Purpose

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 Intervention
Otitis Media
Device: Tube Delivery System (TDS)

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Tympanostomy Tube Placement in Children in the Office (Inova Study)

Resource links provided by NLM:


Further study details as provided by Acclarent:

Primary Outcome Measures:
  • Safety [ Time Frame: procedure up to 2 weeks post procedure ] [ Designated as safety issue: Yes ]
    Adverse events which are procedural, serious, and device-related.

  • Device Success [ Time Frame: Day 0 (day of procedure) ] [ Designated as safety issue: No ]
    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:
  • Procedure Success [ Time Frame: Day 0 (day of procedure) ] [ Designated as safety issue: No ]
    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.

  • Procedure Tolerability [ Time Frame: Day 0 (day of procedure) ] [ Designated as safety issue: No ]
    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.

  • Tube Retention [ Time Frame: 2 weeks post procedure ] [ Designated as safety issue: No ]
    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.


Enrollment: 70
Study Start Date: December 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   6 Months to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01496287

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

No publications provided

Responsible Party: Acclarent
ClinicalTrials.gov Identifier: NCT01496287     History of Changes
Other Study ID Numbers: CPR005027
Study First Received: December 16, 2011
Results First Received: June 26, 2014
Last Updated: June 26, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Otitis Media
Otitis
Ear Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on September 30, 2014