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

NCT03197558 | Completed Phase 2 Results FDA Drug FDA Device

• 1 other identifier: CPR007003 - Group B
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 8

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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

  The VAS consists of a 100 millimeter (mm) line with a statement at each end representing the extreme limits of pain intensity where a score of 0 represents "No pain" and a score of 100 represents "The worst possible pain". Following TDS tube placement, the subject will report their post-tube placement ear discomfort for each ear undergoing tube placement using the VAS. For subjects treated bilaterally, the highest (worst) score reported will be used as the unit of analysis.

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

Study Arms (1)

Tube insertion using Tube Delivery System (TDS)

OTHER

Active Tymbion iontophoresis and tube insertion using the TDS

Combination Product: Tymbion Iontophoresis and Tube Delivery System (TDS)

Interventions

Tymbion Iontophoresis and Tube Delivery System (TDS) COMBINATION_PRODUCT

Subjects will receive active Tymbion iontophoresis and tube insertion using the Tube Delivery System in all ears indicated for tube placement.

Tube insertion using Tube Delivery System (TDS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Tusker Medical: lead

Study Sites (8)

Sacramento ENT

Roseville, California, 95661, United States

Location

Camino ENT

San Jose, California, 95138, United States

Location

Advanced ENT and Allergy

Louisville, Kentucky, 40207, United States

Location

Charlotte Eye Ear Nose and Throat Associates

Charlotte, North Carolina, 28105, United States

Location

Specialty Physician Associates

Bethlehem, Pennsylvania, 18017, United States

Location

South Carolina ENT

Lugoff, South Carolina, 29078, United States

Location

Carolina Ear, Nose and Throat

Orangeburg, South Carolina, 29118, United States

Location

Ear Medical Group

San Antonio, Texas, 78240, United States

Location

MeSH Terms

Conditions

Otitis Media with Effusion; Otitis Media

Condition Hierarchy (Ancestors)

Otitis; Ear Diseases; Otorhinolaryngologic Diseases

Results Point of Contact

• Title: Laura England, PhD
• Organization: Tusker Medical

lengland@tuskermed.com

(650) 223-6909

Study Officials

• David Yen, MD

  Specialty Physician Associates

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2017
• First Posted: June 23, 2017
• Study Start: June 27, 2017
• Primary Completion: September 14, 2017
• Study Completion: September 14, 2017
• Last Updated: January 18, 2020
• Results First Posted: January 18, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)