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

January 6, 2020 updated by: Tusker Medical

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Roseville, California, United States, 95661
        • Sacramento ENT
      • San Jose, California, United States, 95138
        • Camino ENT
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Advanced ENT and Allergy
    • North Carolina
      • Charlotte, North Carolina, United States, 28105
        • Charlotte Eye Ear Nose and Throat Associates
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18017
        • Specialty Physician Associates
    • South Carolina
      • Lugoff, South Carolina, United States, 29078
        • South Carolina ENT
      • Orangeburg, South Carolina, United States, 29118
        • Carolina Ear, Nose and Throat
    • Texas
      • San Antonio, Texas, United States, 78240
        • Ear Medical Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Tube insertion using Tube Delivery System (TDS)
Active Tymbion iontophoresis and tube insertion using the TDS
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Subject-reported Pain Score Following Tube Delivery System (TDS) Tube Placement Using the Visual Analogue Scale (VAS) by Subject Compared to a Performance Goal.
Time Frame: Day of procedure (Day 0)- Immediately after tube placement

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tusker Medical

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David Yen, MD, Specialty Physician Associates

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 27, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 14, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 14, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 20, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 23, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 18, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CPR007003 - Group B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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