In-Office Tympanostomy Tube Placement in Children (OTTER)
NCT ID: NCT03323736
Last Updated: 2022-05-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
370 participants
INTERVENTIONAL
2017-10-31
2021-03-25
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Pivotal Cohort
Active Tymbion iontophoresis and tube insertion using the Tube Delivery System in-office.
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.
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).
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.
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).
Tube placement
Subjects will have tubes placed in the OR using the Tube Delivery System in all ears indicated for tube placement.
Interventions
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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.
Tube placement
Subjects will have tubes placed in the OR using the Tube Delivery System in all ears indicated for tube placement.
Eligibility Criteria
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Inclusion Criteria
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
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.
6 Months
12 Years
ALL
No
Sponsors
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Tusker Medical
INDUSTRY
Responsible Party
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Principal Investigators
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Lawrence Lustig
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Locations
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California Head and Neck Specialists
Carlsbad, California, United States
Sacramento ENT
Roseville, California, United States
Camino Ear Nose & Throat Clinic
San Jose, California, United States
Connecticut Children's Medical Center
Hartford, Connecticut, United States
Yale School of Medicine, Section of Otolaryngology
New Haven, Connecticut, United States
South Florida Pediatric Otolaryngology
Fort Lauderdale, Florida, United States
Nemour's Children's Specialty Care
Jacksonville, Florida, United States
Advanced ENT & Allergy
Louisville, Kentucky, United States
Albany ENT & Allergy Services
Albany, New York, United States
Columbia University Medical Center
New York, New York, United States
Charlotte Ear Eye Nose & Throat Associates, PA
Charlotte, North Carolina, United States
Specialty Physician Associates
Bethlehem, Pennsylvania, United States
South Carolina Ear Nose and Throat
Lugoff, South Carolina, United States
Carolina Ear Nose and Throat Clinic
Orangeburg, South Carolina, United States
Ear Nose and Throat Specialists of Abilene
Abilene, Texas, United States
Frisco ENT for Children
Frisco, Texas, United States
Collin County ENT
Frisco, Texas, United States
Ear Medical Group
San Antonio, Texas, United States
British Columbia Children's Hospital
Vancouver, British Columbia, Canada
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CPR007001
Identifier Type: -
Identifier Source: org_study_id
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