Adult Study to Evaluate Placement of Tympanostomy Tubes In-office (ADEPT)

Completed · Phase 2

Conditions studied: Barotrauma;Ear, OME - Otitis Media With Effusion, AOM - Acute Otitis Media, Eustachian Tube Dysfunction

In brief

A prospective, multicenter study to evaluate effectiveness and safety of Tymbion iontophoresis and tympanostomy tube placement using the Tula iontophoresis and tube delivery systems for adults in an office setting. This study cohort is called Group B and includes tube placement. Protocol CPR007003 also included a first study group ('A', without tube placement) that was completed and described in a separate registration (NCT03119181).

Key facts

Study ID

NCT03197558

Run by

Tusker Medical

People needed

30

Starts

2017-06-27

Expected to finish

2017-09-14

Last updated by the study team

2020-01-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults at least 18 years of age at time of consent
• Indication for tympanostomy tube insertion per Clinical Practice Guideline,or indicated for tympanostomy tube insertion due to barotrauma or Eustachian tube dysfunction per AAO-HNS Clinical Indicators.
• Subject is able and willing to comply with the protocol and attend all study visits.
• Subject is able and willing to provide informed consent.
• Subject is able to read and understand English.
• Exclusion Criteria by Ear:
• Significantly atrophic, retracted or retraction pocket at location of tube placement, bimeric, monomeric or atelectatic tympanic membrane.
• Perforated tympanic membrane.
• Otitis externa.
• 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.
• Notable ear discomfort experienced during audiologic or otoscopic examination.
• 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.
• General Exclusion Criteria
• Pregnant or lactating females
• History of sensitivity or allergic reaction to lidocaine HCl, tetracaine, epinephrine, or any hypersensitivity to local anesthetics.
• Familial history of insensitivity to lidocaine or other local anesthetics of the amide type.
• 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

Where it is running

• Sacramento ENT — Roseville, California, United States
• Camino ENT — San Jose, California, United States
• Advanced ENT and Allergy — Louisville, Kentucky, United States
• Charlotte Eye Ear Nose and Throat Associates — Charlotte, North Carolina, United States
• Specialty Physician Associates — Bethlehem, Pennsylvania, United States
• South Carolina ENT — Lugoff, South Carolina, United States
• Carolina Ear, Nose and Throat — Orangeburg, South Carolina, United States
• Ear Medical Group — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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