NCT03197558

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

A Prospective, Multicenter Study to Evaluate Effectiveness and Safety of Lidocaine Iontophoresis and Tympanostomy Tube Placement Using the Tula Iontophoresis and Tube Delivery Systems for Adults in an Office Setting

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Tusker Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The objective for Group B in the study is to evaluate tolerability and safety of tympanostomy tube (TT) placement in adults following local anesthesia in a physician's clinic setting. Group B will consist of 30 evaluable adults who require unilateral or bilateral tube insertion. The iontophoresis system (IPS) will be used to facilitate anesthetic delivery to the tympanic membrane (TM). The lidocaine-based solution used for local anesthesia of the TM is Tymbion (2% lidocaine HCl/ 1:100,000 epinephrine). Subjects will receive active Tymbion iontophoresis and will have tubes placed using the TDS in all ears indicated for tube placement. The subject will rate the pain upon TDS tube insertion using the VAS, and the pain score will be compared to a performance goal. Safety will be evaluated post procedure and at a follow-up visit.

Conditions

• Barotrauma;Ear
• OME - Otitis Media With Effusion
• AOM - Acute Otitis Media
• Eustachian Tube Dysfunction

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Tymbion Iontophoresis and Tube Delivery System (TDS)	Subjects will receive active Tymbion iontophoresis and tube insertion using the Tube Delivery System in all ears indicated for tube placement.

Timeline

• Start date: 2017-06-27
• Primary completion: 2017-09-14
• Completion: 2017-09-14
• First posted: 2017-06-23
• Last updated: 2020-01-18
• Results posted: 2020-01-18

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study