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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: November 4, 2014
Last verified: November 2014

December 16, 2011
November 4, 2014
December 2011
April 2012   (final data collection date for primary outcome measure)
  • Number of Participants With Procedural, Serious, and Device-Related Adverse Events [ 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.
  • 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
Complete list of historical versions of study NCT01496287 on ClinicalTrials.gov Archive Site
  • 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.

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

  • 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.
  • 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
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 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 (TDS)
Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system under local anesthesia in an office/clinic setting
Other Name: Tula TDS
Experimental: Tube placement group
Intervention: Device: Tube Delivery System (TDS)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
April 2012
April 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 information is only displayed when the study is recruiting subjects
United States
 
NCT01496287
CPR005027
No
Acclarent
Acclarent
Not Provided
Principal Investigator: Jacob W Zeiders, M.D. South Coast Ear, Nose & Throat
Acclarent
November 2014

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