In-Office Tympanostomy Tube Placement in Children (OTTER) (OTTER)

A Prospective, Single-arm, Multicenter Study to Evaluate Effectiveness and Safety of Tympanostomy Tube Placement Using the Tula Iontophoresis and Tube Delivery Systems for Children in an Office Setting.

A prospective, single-arm, multicenter study to evaluate effectiveness and safety of Tymbion iontophoresis and tympanostomy tube placement using the Tula Iontophoresis and Tube Delivery Systems for children in an office setting.

Study Overview

• Status: Completed
• Conditions: AOM - Acute Otitis Media; OME - Otitis Media With Effusion
• Intervention / Treatment: Combination product: Iontophoresis & tube placement; Device: Tube placement

Detailed Description

The objective of this study is to evaluate effectiveness and safety of tympanostomy tube (TT) placement in children following local anesthesia in a physician's clinic setting (henceforth referred to as 'in-office'). Local anesthesia using Tymbion, a lidocaine-based anesthetic, is delivered by the Tula Iontophoresis System (IPS) and TT placement is implemented by the Tula Tube Delivery System (TDS).

The IPS will be used to facilitate anesthetic delivery to the tympanic membrane (TM). The Iontophoresis System consists of an Iontophoresis Control Unit, Iontophoresis Earsets and a return electrode patch. The Control Unit monitors and delivers a fixed amount of charge (ie, dose) to the patient through the Earsets(s) and alerts the operator when charge delivery is complete. The lidocaine-based solution used for local anesthesia of the TM is Tymbion (2% lidocaine HCl/ 1:100,000 epinephrine).

The TDS is a mechanical device that integrates a myringotomy blade, tympanostomy tube and tube inserter for TT placement with a user-controlled activation. The study will use the TDS with a grommet-type tube.

This pivotal study will include up to 422 children ages 6 months through 12 years indicated for tympanostomy tube placement enrolled at approximately 15 to 25 investigational centers in the US and Canada. The pivotal cohort consists of 222 subjects. In addition, up to 100 subjects will be enrolled as lead-in procedures in the OR using the TDS and up to 100 subjects will be enrolled as lead-in procedure in-office (using IPS and TDS) as the surgeons' initial experience with the technology prior to enrolling into the pivotal cohort.

All pivotal and lead-in subjects will follow the same study protocol assessments and visit schedule consisting of a screening visit, procedure visit and 3-week, 6 month, 12 month, 18 month, and 24 month post-procedure follow-up visits. Lead-in procedures will be analyzed separately from the pivotal pediatric cohort.

• Study Type: Interventional
• Enrollment (Actual): 370
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6H 3N1
      • British Columbia Children's Hospital
• United States
  • California
    • Carlsbad, California, United States, 92008
      • California Head and Neck Specialists
    • Roseville, California, United States, 95661
      • Sacramento ENT
    • San Jose, California, United States, 95138
      • Camino Ear Nose & Throat Clinic
  • Connecticut
    • Hartford, Connecticut, United States, 06106
      • Connecticut Children's Medical Center
    • New Haven, Connecticut, United States, 06510
      • Yale School of Medicine, Section of Otolaryngology
  • Florida
    • Fort Lauderdale, Florida, United States, 33316
      • South Florida Pediatric Otolaryngology
    • Jacksonville, Florida, United States, 32207
      • Nemour's Children's Specialty Care
  • Kentucky
    • Louisville, Kentucky, United States, 40207
      • Advanced ENT & Allergy
  • New York
    • Albany, New York, United States, 12206
      • Albany ENT & Allergy Services
    • New York, New York, United States, 10032
      • Columbia University Medical Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28105
      • Charlotte Ear Eye Nose & Throat Associates, PA
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18017
      • Specialty Physician Associates
  • South Carolina
    • Lugoff, South Carolina, United States, 29078
      • South Carolina Ear Nose and Throat
    • Orangeburg, South Carolina, United States, 29118
      • Carolina Ear Nose and Throat Clinic
  • Texas
    • Abilene, Texas, United States, 79601
      • Ear Nose and Throat Specialists of Abilene
    • Frisco, Texas, United States, 75034
      • Collin County ENT
    • Frisco, Texas, United States, 75033
      • Frisco ENT for Children
    • San Antonio, Texas, United States, 78240
      • Ear Medical Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Males or females at least 6 months old through 12 years old at time of consent
2. Indication for tympanostomy tube insertion per Clinical Practice Guideline
3. Behavioral capacity and cooperative temperament to undergo an awake procedure, based on physician judgment (not applicable to OR Lead-In subjects)
4. Subject's parent/guardian and subject are able and willing to comply with the protocol and attend all study visits
5. Subject's parent/guardian and subject are able and willing to provide informed consent or assent as age appropriate

Exclusion Criteria:

1. Significantly atrophic, retracted, bimeric, monomeric or atelectatic tympanic membrane
2. Perforated tympanic membrane
3. Otitis externa
4. Active or recent conditions of the tympanic membrane (eg, prior myringotomy with incomplete wound healing or re-epithelization)
5. Hemotympanum
6. Damaged/denuded skin in the auditory canal
7. 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
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
10. History of sensitivity or allergic reaction to lidocaine HCl, tetracaine, epinephrine, or any hypersensitivity to local anesthetics of the amide type, or any component of the anesthetic drug formulation (not applicable to OR Lead-In subjects)
11. Familial history of insensitivity to lidocaine or other local anesthetics of the amide type (eg, history of inadequate anesthesia with dental numbing agents). (not applicable to OR Lead-In subjects)
12. Electrically sensitive medical support systems (eg, pacemakers, defibrillators, cochlear implants)
13. Other conditions that would preclude performing the study procedure including iontophoresis system ear plug incompatibility.
14. 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.
15. Subject is 4 years or older and not able to complete all baseline assessments. Subject is younger than 4 years and not able to complete all baseline assessments, not including audiometry.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Pivotal Cohort; Active Tymbion iontophoresis and tube insertion using the Tube Delivery System in-office.	Combination product: Iontophoresis & tube placement; Subjects will receive active Tymbion iontophoresis and will have tubes placed in-office using the Tube Delivery System in all ears indicated for tube placement.
Other: Office Lead-In Cohort; Active Tymbion iontophoresis and tube insertion using the Tube Delivery System in-office. Physician initial in-office iontophoresis and tube insertion procedures (minimum of 2 subjects per investigator).	Combination product: Iontophoresis & tube placement; Subjects will receive active Tymbion iontophoresis and will have tubes placed in-office using the Tube Delivery System in all ears indicated for tube placement.
Other: OR Lead-In Cohort; Tubes insertion using the Tube Delivery System in the operating room (OR). Physician initial tube insertion procedures in the OR (minimum of 2 subjects per investigator).	Device: Tube placement; Subjects will have tubes placed in the OR using the Tube Delivery System in all ears indicated for tube placement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural Success:	Count (and percentage) of subjects in the pivotal cohort with successful placement of Tusker Medical tympanostomy tubes in all indicated ears in an office procedure. Note: the primary endpoint applies only to the Pivotal Cohort, and not to the OR Lead-In or Office Lead-In cohorts.	Day of Procedure (Day 0) Immediately following tube placement
Tube Placement Tolerability	Mean subject-reported pain score following TDS tube placement using the Faces Pain Scale-Revised (FPS-R) (pivotal cohort children ages 5 and older only). The FPS-R has 6 faces which permits scaling to a 0-to-10 scoring system in intervals of 2 (ie 0, 2, 4, 6, 8 and 10), where 0 represents 'no pain' and 10 represents 'very much pain'. Note- the primary endpoint applies only to the Pivotal Cohort, and not to the OR Lead-In or Office Lead-In cohorts.	Day of Procedure (Day 0) Immediately following tube placement

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tube Patency	Count (and percentage) of subjects in the pivotal cohort, in which a Tusker Medical tube was successfully placed, with functionally patent tube(s) at the 3-week post-procedure follow-up visit. Note- thus secondary endpoint applies only to the Pivotal Cohort, and not to the OR Lead-In or Office Lead-In cohorts. Note - This endpoint includes subjects for which at least 1 ear had successful tube placement. For bilateral subjects, they may be considered a non-successful procedure if only 1 ear had successful tube placement, however would be evaluated for the Tube Patency endpoint for the ear that was successful.	3 Weeks Post Procedure
Tube Retention	Count (percentage) of subjects in the pivotal cohort, in which a Tusker Medical tube(s) was successfully placed, with presence of a Tusker Medical tube across the TM in all successfully treated ears at the 3-week post-procedure follow-up visit. Note- the secondary endpoint applies only to the Pivotal Cohort, and not to the OR Lead-In or Office Lead-In cohorts. Note - This endpoint includes subjects for which at least 1 ear had successful tube placement. For bilateral subjects, they may be considered a non-successful procedure if only 1 ear had successful tube placement, however would be evaluated for the Tube Retention endpoint for the ear that was successful.	3 Weeks Post Procedure
Anesthesia Effectiveness	Count (percentage) of subjects in the pivotal cohort, who completed iontophoresis for all indicated ears, with adequate anesthesia for TT placement in all treated ears as determined by physician's evaluation of TM anesthesia prior to tube placement. Note- the secondary endpoint applies only to the Pivotal Cohort, and not to the OR Lead-In or Office Lead-In cohorts.	Day of Procedure (Day 0)

Collaborators and Investigators

• Sponsor: Tusker Medical
• Investigators: Principal Investigator: Lawrence Lustig, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2017
• Primary Completion (Actual): February 28, 2019
• Study Completion (Actual): March 25, 2021

Study Registration Dates

• First Submitted: October 24, 2017
• First Submitted That Met QC Criteria: October 24, 2017
• First Posted (Actual): October 27, 2017

Study Record Updates

• Last Update Posted (Actual): May 26, 2022
• Last Update Submitted That Met QC Criteria: May 3, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Ear Diseases; Otitis; Otitis Media; Otitis Media with Effusion
• Other Study ID Numbers: CPR007001

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