CompletedPhase 2

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

United States30 participantsStarted 2017-06-27

Plain-language summary

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).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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

✕. 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.

What they're measuring

Subject-reported Pain Score Following Tube Delivery System (TDS) Tube Placement Using the Visual Analogue Scale (VAS) by Subject Compared to a Performance Goal.

Timeframe: Day of procedure (Day 0)- Immediately after tube placement

Trial details

NCT IDNCT03197558

SponsorTusker Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-09-14

Results submitted2019-12-17

View on ClinicalTrials.gov More Barotrauma;Ear trials