Evaluation of Outcomes Following In-office Tympanostomy Using the Tula® System: a Prospective, Multi-center Registry
NCT ID: NCT05915078
Last Updated: 2024-07-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2023-06-15
2027-06-30
Brief Summary
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The FDA-approved Tula System includes the Tula Iontophoresis System (IPS) with TYMBION™ otic anesthetic for local anesthesia of the ear drum and the Tula Tube Delivery System (TDS) for ear tube placement. Clinical research established the safety, efficacy and tolerability of this system for in-office procedures in the pediatric population. Patients will be treated and evaluated according to standard medical care. Outcome data is collected up to 6 months following extrusion or removal of their tube(s).
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Tula Tympanostomy
Patients undergoing in-office tympanostomy using the Tula® System
Iontophoresis and tube placement
Iontophoretic delivery of TYMBION™ otic anesthetic using the Tula Iontophoresis System and tube insertion using the Tula Tube Delivery System
Interventions
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Iontophoresis and tube placement
Iontophoretic delivery of TYMBION™ otic anesthetic using the Tula Iontophoresis System and tube insertion using the Tula Tube Delivery System
Eligibility Criteria
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Inclusion Criteria
* Patients who are candidates for in-office tube placement using the Tula System according to the System Instructions For Use
Exclusion Criteria
6 Months
17 Years
ALL
No
Sponsors
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Smith & Nephew, Inc.
INDUSTRY
Responsible Party
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Locations
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Advanced ENT and Allergy
Louisville, Kentucky, United States
Regional Otolaryngology Head and Neck Associates
Cherry Hill, New Jersey, United States
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
Columbia University Vagelos College of Physicians and Surgeons
New York, New York, United States
Ogden Clinic - Professional Center North
Ogden, Utah, United States
Peak Pediatric Ear, Nose and Throat
Provo, Utah, United States
Countries
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Central Contacts
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Facility Contacts
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Megan Morgan
Role: primary
Kelvin M Kwong
Role: primary
Ashley Erickson
Role: primary
Jordan C Schramm
Role: primary
Other Identifiers
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Tula Registry
Identifier Type: -
Identifier Source: org_study_id
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