In-Office Tympanostomy Tube Placement in Children (OTTER)
Condition: OME - Otitis Media With Effusion; AOM - Acute Otitis Media
MeSH terms: Otitis; Otitis Media; Otitis Media with Effusion
Study type: Interventional
Phase: Phase 3

Summary: 
      A prospective, single-arm, multicenter study to evaluate effectiveness and safety of Tymbion
      iontophoresis and tympanostomy tube placement using the Tula Iontophoresis and Tube Delivery
      Systems for children in an office setting.
    

Detailed description: 
      The objective of this study is to evaluate effectiveness and safety of tympanostomy tube (TT)
      placement in children following local anesthesia in a physician's clinic setting (henceforth
      referred to as 'in-office'). Local anesthesia using Tymbion, a lidocaine-based anesthetic, is
      delivered by the Tula Iontophoresis System (IPS) and TT placement is implemented by the Tula
      Tube Delivery System (TDS).

      The IPS will be used to facilitate anesthetic delivery to the tympanic membrane (TM). The
      Iontophoresis System consists of an Iontophoresis Control Unit, Iontophoresis Earsets and a
      return electrode patch. The Control Unit monitors and delivers a fixed amount of charge (ie,
      dose) to the patient through the Earsets(s) and alerts the operator when charge delivery is
      complete. The lidocaine-based solution used for local anesthesia of the TM is Tymbion (2%
      lidocaine HCl/ 1:100,000 epinephrine).

      The TDS is a mechanical device that integrates a myringotomy blade, tympanostomy tube and
      tube inserter for TT placement with a user-controlled activation. The study will use the TDS
      with a grommet-type tube.

      This pivotal study will include up to 422 children ages 6 months through 12 years indicated
      for tympanostomy tube placement enrolled at approximately 15 to 25 investigational centers in
      the US and Canada. The pivotal cohort consists of 222 subjects. In addition, up to 100
      subjects will be enrolled as lead-in procedures in the OR using the TDS and up to 100
      subjects will be enrolled as lead-in procedure in-office (using IPS and TDS) as the surgeons'
      initial experience with the technology prior to enrolling into the pivotal cohort.

      All pivotal and lead-in subjects will follow the same study protocol assessments and visit
      schedule consisting of a screening visit, procedure visit and 3-week, 6 month, 12 month, 18
      month, and 24 month post-procedure follow-up visits. Lead-in procedures will be analyzed
      separately from the pivotal pediatric cohort.
    

Intervention name(s): Iontophoresis & tube placement; Tube placement
Intervention type(s): Combination Product; Device
Intervention description(s): Subjects will receive active Tymbion iontophoresis and will have tubes placed in-office using the Tube Delivery System in all ears indicated for tube placement.; Subjects will have tubes placed in the OR using the Tube Delivery System in all ears indicated for tube placement.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: Pivotal cohort is single arm. Physician initial subjects evaluated in separate cohorts but not included in primary and secondary analyses.
Masking: None (Open Label)
Primary purpose: Treatment