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

Primary Purpose

Barotrauma;Ear, OME - Otitis Media With Effusion, AOM - Acute Otitis Media

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tymbion Iontophoresis and Tube Delivery System (TDS)
Sponsored by
Tusker Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Barotrauma;Ear

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sacramento ENT
  • Camino ENT
  • Advanced ENT and Allergy
  • Charlotte Eye Ear Nose and Throat Associates
  • Specialty Physician Associates
  • South Carolina ENT
  • Carolina Ear, Nose and Throat
  • Ear Medical Group

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Tube insertion using Tube Delivery System (TDS)

Arm Description

Active Tymbion iontophoresis and tube insertion using the TDS

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 20, 2017
Last Updated
January 6, 2020
Sponsor
Tusker Medical
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1. Study Identification

Unique Protocol Identification Number
NCT03197558
Brief Title
Adult Study to Evaluate Placement of Tympanostomy Tubes In-office (ADEPT)
Acronym
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

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
June 27, 2017 (Actual)
Primary Completion Date
September 14, 2017 (Actual)
Study Completion Date
September 14, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tusker Medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Barotrauma;Ear, OME - Otitis Media With Effusion, AOM - Acute Otitis Media, Eustachian Tube Dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tube insertion using Tube Delivery System (TDS)
Arm Type
Other
Arm Description
Active Tymbion iontophoresis and tube insertion using the TDS
Intervention Type
Combination Product
Intervention Name(s)
Tymbion Iontophoresis and Tube Delivery System (TDS)
Intervention Description
Subjects will receive active Tymbion iontophoresis and tube insertion using the Tube Delivery System in all ears indicated for tube placement.
Primary Outcome Measure Information:
Title
Subject-reported Pain Score Following Tube Delivery System (TDS) Tube Placement Using the Visual Analogue Scale (VAS) by Subject Compared to a Performance Goal.
Description
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.
Time Frame
Day of procedure (Day 0)- Immediately after tube placement

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Yen, MD
Organizational Affiliation
Specialty Physician Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sacramento ENT
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
Camino ENT
City
San Jose
State/Province
California
ZIP/Postal Code
95138
Country
United States
Facility Name
Advanced ENT and Allergy
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Charlotte Eye Ear Nose and Throat Associates
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28105
Country
United States
Facility Name
Specialty Physician Associates
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18017
Country
United States
Facility Name
South Carolina ENT
City
Lugoff
State/Province
South Carolina
ZIP/Postal Code
29078
Country
United States
Facility Name
Carolina Ear, Nose and Throat
City
Orangeburg
State/Province
South Carolina
ZIP/Postal Code
29118
Country
United States
Facility Name
Ear Medical Group
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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