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

This study is currently recruiting participants.
Verified December 2011 by Acclarent
Sponsor:
Information provided by (Responsible Party):
Acclarent
ClinicalTrials.gov Identifier:
NCT01496287
First received: December 16, 2011
Last updated: December 19, 2011
Last verified: December 2011
History of Changes

December 16, 2011
December 19, 2011
December 2011
May 2012   (final data collection date for primary outcome measure)
  • Safety [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
    Those adverse events which are procedural, serious, and device-related.
  • Device Effectiveness [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    The successful delivery of the tympanostomy tube across the tympanic membrane
Same as current
Complete list of historical versions of study NCT01496287 on ClinicalTrials.gov Archive Site
  • Procedure Success [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    Successful placement of any tympanostomy tube, with no safety events
  • Tube placement tolerability [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    Subject reporting of level of tolerability using the Wong-Baker FACES scale (0-5)
  • Tube Retention [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Presence of the tympanostomy tube across the tympanic membrane at the follow-up visit
Same as current
Not Provided
Not Provided
 
Tympanostomy Tube Placement in Children in the Office (Inova Study)
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 delivered by iontophoresis in an office/clinic setting.
Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Otitis Media
Device: Tube Delivery System (Tula)
Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device
Other Name: Tula TDS
Experimental: Tube placement group
Intervention: Device: Tube Delivery System (Tula)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
May 2012
May 2012   (final data collection date for primary outcome measure)

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
Both
6 Months to 21 Years
No
Contact: Robert K Sink, Ph.D. 650-687-4820 rsink@its.jnj.com
United States
 
NCT01496287
CPR005027
No
Acclarent
Acclarent
Not Provided
Principal Investigator: Jacob W Zeiders, M.D. South Coast Ear, Nose & Throat
Acclarent
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP