In-Office Tympanostomy Tube Placement in Children (OTTER)

Completed · Phase 3

Conditions studied: OME - Otitis Media With Effusion, AOM - Acute Otitis Media

In brief

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.

Key facts

Study ID

NCT03323736

Run by

Tusker Medical

People needed

370

Starts

2017-10-31

Expected to finish

2021-03-25

Last updated by the study team

2022-05-26

Who can join

Age: 1 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males or females at least 6 months old through 12 years old at time of consent
• Indication for tympanostomy tube insertion per Clinical Practice Guideline
• Behavioral capacity and cooperative temperament to undergo an awake procedure, based on physician judgment (not applicable to OR Lead-In subjects)
• Subject's parent/guardian and subject are able and willing to comply with the protocol and attend all study visits
• Subject's parent/guardian and subject are able and willing to provide informed consent or assent as age appropriate

You may not qualify if…

• Significantly atrophic, retracted, bimeric, monomeric or atelectatic tympanic membrane
• Perforated tympanic membrane
• Otitis externa
• Active or recent conditions of the tympanic membrane (eg, prior myringotomy with incomplete wound healing or re-epithelization)
• Hemotympanum
• Damaged/denuded skin in the auditory canal
• Cerumen impaction resulting in a significant amount of cleaning required to visualize the tympanic membrane potentially causing abrasion or irritation to the external ear canal
• Anatomy that precludes sufficient visualization of and access to the tympanic membrane
• Anatomy that necessitates tympanostomy tube placement in the posterior half of the tympanic membrane
• History of sensitivity or allergic reaction to lidocaine HCl, tetracaine, epinephrine, or any hypersensitivity to local anesthetics of the amide type, or any component of the anesthetic drug formulation (not applicable to OR Lead-In subjects)
• Familial history of insensitivity to lidocaine or other local anesthetics of the amide type (eg, history of inadequate anesthesia with dental numbing agents). (not applicable to OR Lead-In subjects)
• Electrically sensitive medical support systems (eg, pacemakers, defibrillators, cochlear implants)
• Other conditions that would preclude performing the study procedure including iontophoresis system ear plug incompatibility.
• Health conditions that, in the opinion of the investigator, would present undue risk to the subject, based on device/anesthetic drug product label warnings and precautions.
• Subject is 4 years or older and not able to complete all baseline assessments. Subject is younger than 4 years and not able to complete all baseline assessments, not including audiometry.

Where it is running

• California Head and Neck Specialists — Carlsbad, California, United States
• Sacramento ENT — Roseville, California, United States
• Camino Ear Nose & Throat Clinic — San Jose, California, United States
• Connecticut Children's Medical Center — Hartford, Connecticut, United States
• Yale School of Medicine, Section of Otolaryngology — New Haven, Connecticut, United States
• South Florida Pediatric Otolaryngology — Fort Lauderdale, Florida, United States
• Nemour's Children's Specialty Care — Jacksonville, Florida, United States
• Advanced ENT & Allergy — Louisville, Kentucky, United States
• Albany ENT & Allergy Services — Albany, New York, United States
• Columbia University Medical Center — New York, New York, United States
• Charlotte Ear Eye Nose & Throat Associates, PA — Charlotte, North Carolina, United States
• Specialty Physician Associates — Bethlehem, Pennsylvania, United States
• South Carolina Ear Nose and Throat — Lugoff, South Carolina, United States
• Carolina Ear Nose and Throat Clinic — Orangeburg, South Carolina, United States
• Ear Nose and Throat Specialists of Abilene — Abilene, Texas, United States
• Frisco ENT for Children — Frisco, Texas, United States
• Collin County ENT — Frisco, Texas, United States
• Ear Medical Group — San Antonio, Texas, United States
• British Columbia Children's Hospital — Vancouver, British Columbia, Canada

Full record on ClinicalTrials.gov

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