In-Office Tympanostomy Tube Placement in Children (OTTER)

Phase 3

Completed

Conditions: OME - Otitis Media With Effusion
AOM - Acute Otitis Media

Interventions: Device: Tube placement
Combination Product: Iontophoresis & tube placement

Registration Number: NCT03323736

Lead Sponsor: Tusker Medical

Brief Summary: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 370

Inclusion Criteria

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

Exclusion Criteria

Significantly atrophic, retracted, bimeric, monomeric or atelectatic tympanic membrane
Perforated tympanic membrane
Otitis externa
Active or recent conditions of the tympanic membrane (eg, prior myringotomy with incomplete wound healing or re-epithelization)
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
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
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)
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)
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.
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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OR Lead-In Cohort	Tube placement	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).
Pivotal Cohort	Iontophoresis & tube placement	Active Tymbion iontophoresis and tube insertion using the Tube Delivery System in-office.
Office Lead-In Cohort	Iontophoresis & tube placement	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).

Primary Outcome Measures

Name	Time	Method
Procedural Success:	Day of Procedure (Day 0) Immediately following tube placement	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.
Tube Placement Tolerability	Day of Procedure (Day 0) Immediately following tube placement	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.

Secondary Outcome Measures

Name	Time	Method
Tube Patency	3 Weeks Post Procedure	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.
Tube Retention	3 Weeks Post Procedure	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.
Anesthesia Effectiveness	Day of Procedure (Day 0)	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.

Trial Locations

Locations (19): Connecticut Children's Medical Center
🇺🇸
Hartford, Connecticut, United States
South Florida Pediatric Otolaryngology
🇺🇸
Fort Lauderdale, Florida, United States
Yale School of Medicine, Section of Otolaryngology
🇺🇸
New Haven, Connecticut, United States
Columbia University Medical Center
🇺🇸
New York, New York, United States
Camino Ear Nose & Throat Clinic
🇺🇸
San Jose, California, United States
California Head and Neck Specialists
🇺🇸
Carlsbad, California, United States
Sacramento ENT
🇺🇸
Roseville, California, United States
Carolina Ear Nose and Throat Clinic
🇺🇸
Orangeburg, South Carolina, United States
Frisco ENT for Children
🇺🇸
Frisco, Texas, United States
Collin County ENT
🇺🇸
Frisco, Texas, United States
Nemour's Children's Specialty Care
🇺🇸
Jacksonville, Florida, United States
South Carolina Ear Nose and Throat
🇺🇸
Lugoff, South Carolina, United States
Albany ENT & Allergy Services
🇺🇸
Albany, New York, United States
Specialty Physician Associates
🇺🇸
Bethlehem, Pennsylvania, United States
Charlotte Ear Eye Nose & Throat Associates, PA
🇺🇸
Charlotte, North Carolina, United States
Ear Nose and Throat Specialists of Abilene
🇺🇸
Abilene, Texas, United States
British Columbia Children's Hospital
🇨🇦
Vancouver, British Columbia, Canada
Ear Medical Group
🇺🇸
San Antonio, Texas, United States
Advanced ENT & Allergy
🇺🇸
Louisville, Kentucky, United States