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

Primary Purpose

OME - Otitis Media With Effusion, AOM - Acute Otitis Media

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Iontophoresis & tube placement
Tube placement
Sponsored by
Tusker Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for OME - Otitis Media With Effusion

Eligibility Criteria

6 Months - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • California Head and Neck Specialists
  • Sacramento ENT
  • Camino Ear Nose & Throat Clinic
  • Connecticut Children's Medical Center
  • Yale School of Medicine, Section of Otolaryngology
  • South Florida Pediatric Otolaryngology
  • Nemour's Children's Specialty Care
  • Advanced ENT & Allergy
  • Albany ENT & Allergy Services
  • Columbia University Medical Center
  • Charlotte Ear Eye Nose & Throat Associates, PA
  • Specialty Physician Associates
  • South Carolina Ear Nose and Throat
  • Carolina Ear Nose and Throat Clinic
  • Ear Nose and Throat Specialists of Abilene
  • Frisco ENT for Children
  • Collin County ENT
  • Ear Medical Group
  • British Columbia Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Pivotal Cohort

Office Lead-In Cohort

OR Lead-In Cohort

Arm Description

Active Tymbion iontophoresis and tube insertion using the Tube Delivery System in-office.

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).

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).

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
October 24, 2017
Last Updated
May 3, 2022
Sponsor
Tusker Medical
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1. Study Identification

Unique Protocol Identification Number
NCT03323736
Brief Title
In-Office Tympanostomy Tube Placement in Children (OTTER)
Acronym
OTTER
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
October 31, 2017 (Actual)
Primary Completion Date
February 28, 2019 (Actual)
Study Completion Date
March 25, 2021 (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, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
OME - Otitis Media With Effusion, AOM - Acute Otitis Media

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
Pivotal cohort is single arm. Physician initial subjects evaluated in separate cohorts but not included in primary and secondary analyses.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
370 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pivotal Cohort
Arm Type
Other
Arm Description
Active Tymbion iontophoresis and tube insertion using the Tube Delivery System in-office.
Arm Title
Office Lead-In Cohort
Arm Type
Other
Arm Description
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).
Arm Title
OR Lead-In Cohort
Arm Type
Other
Arm Description
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).
Intervention Type
Combination Product
Intervention Name(s)
Iontophoresis & tube placement
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Tube placement
Intervention Description
Subjects will have tubes placed in the OR using the Tube Delivery System in all ears indicated for tube placement.
Primary Outcome Measure Information:
Title
Procedural Success:
Description
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.
Time Frame
Day of Procedure (Day 0) Immediately following tube placement
Title
Tube Placement Tolerability
Description
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.
Time Frame
Day of Procedure (Day 0) Immediately following tube placement
Secondary Outcome Measure Information:
Title
Tube Patency
Description
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.
Time Frame
3 Weeks Post Procedure
Title
Tube Retention
Description
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.
Time Frame
3 Weeks Post Procedure
Title
Anesthesia Effectiveness
Description
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.
Time Frame
Day of Procedure (Day 0)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence Lustig
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
California Head and Neck Specialists
City
Carlsbad
State/Province
California
ZIP/Postal Code
92008
Country
United States
Facility Name
Sacramento ENT
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
Camino Ear Nose & Throat Clinic
City
San Jose
State/Province
California
ZIP/Postal Code
95138
Country
United States
Facility Name
Connecticut Children's Medical Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
Yale School of Medicine, Section of Otolaryngology
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
South Florida Pediatric Otolaryngology
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Nemour's Children's Specialty Care
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Advanced ENT & Allergy
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Albany ENT & Allergy Services
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Charlotte Ear Eye Nose & Throat Associates, PA
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 Ear Nose and Throat
City
Lugoff
State/Province
South Carolina
ZIP/Postal Code
29078
Country
United States
Facility Name
Carolina Ear Nose and Throat Clinic
City
Orangeburg
State/Province
South Carolina
ZIP/Postal Code
29118
Country
United States
Facility Name
Ear Nose and Throat Specialists of Abilene
City
Abilene
State/Province
Texas
ZIP/Postal Code
79601
Country
United States
Facility Name
Frisco ENT for Children
City
Frisco
State/Province
Texas
ZIP/Postal Code
75033
Country
United States
Facility Name
Collin County ENT
City
Frisco
State/Province
Texas
ZIP/Postal Code
75034
Country
United States
Facility Name
Ear Medical Group
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
British Columbia Children's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3N1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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In-Office Tympanostomy Tube Placement in Children (OTTER)

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