Clinical trial NCT03197558: Adult Study to Evaluate Placement of Tympanostomy Tubes In-office (ADEPT)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Barotrauma;Ear
OME - Otitis Media With Effusion
AOM - Acute Otitis Media
Eustachian Tube Dysfunction
Lead sponsor: Tusker Medical
Sponsor class: INDUSTRY
First posted: 2017-06-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Adults at least 18 years of age at time of consent
2. 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.
3. Subject is able and willing to comply with the protocol and attend all study visits.
4. Subject is able and willing to provide informed consent.
5. Subject is able to read and understand English.

Exclusion Criteria by Ear:

1. Significantly atrophic, retracted or retraction pocket at location of tube placement, bimeric, monomeric or atelectatic tympanic membrane.
2. Perforated tympanic membrane.
3. Otitis externa.
4. Hemotympanum.
5. Damaged/denuded skin in the auditory canal.
6. 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.
7. Notable ear discomfort experienced during audiologic or otoscopic examination.
8. Anatomy that precludes sufficient visualization of and access to the tympanic membrane.
9. Anatomy that necessitates tympanostomy tube placement in the posterior half of the tympanic membrane.

   General Exclusion Criteria
10. Pregnant or lactating females
11. History of sensitivity or allergic reaction to lidocaine HCl, tetracaine, epinephrine, or any hypersensitivity to local anesthetics.
12. Familial history of insensitivity to lidocaine or other local anesthetics of the amide type.
13. Electrically sensitive medical support systems (eg, pacemakers, defibrillators, cochlear implants)
14. Other conditions that would preclude performing the study procedure including iontophoresis system ear plug incompatibility.
15. 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

Primary outcomes:
measure: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Roseville
country: United States
facility: Sacramento ENT
state: California
city: San Jose
country: United States
facility: Camino ENT
state: California
city: Louisville
country: United States
facility: Advanced ENT and Allergy
state: Kentucky
city: Charlotte
country: United States
facility: Charlotte Eye Ear Nose and Throat Associates
state: North Carolina
city: Bethlehem
country: United States
facility: Specialty Physician Associates
state: Pennsylvania
city: Lugoff
country: United States
facility: South Carolina ENT
state: South Carolina
city: Orangeburg
country: United States
facility: Carolina Ear, Nose and Throat
state: South Carolina
city: San Antonio
country: United States
facility: Ear Medical Group
state: Texas
Study officials:
affiliation: Specialty Physician Associates
name: David Yen, MD
role: PRINCIPAL_INVESTIGATOR
References: