Clinical trial NCT05915078: Evaluation of Outcomes Following In-office Tympanostomy Using the Tula® System: a Prospective, Multi-center Registry
Official title: Evaluation of Clinical and Health Economic Outcomes Following In-office Tympanostomy Using the Tula® System: a Prospective, Multi-center Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Otitis Media With Effusion
Acute Otitis Media
Otitis Media
Keywords: Otitis media
pediatric
tympanostomy
office procedure
local anesthesia
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2023-06-22
Enrollment: 200
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participating centers will invite eligible patients ages 6 months to 17 years of age indicated for tympanostomy to participate in the Registry

Brief summary: This prospective, single-arm, multicenter registry is being conducted to collect real world post-market data from patients aged from 6 months to 17 years of age who are undergoing an in-office ear tube placement procedure (tympanostomy) using the Tula® System. The Registry will include up to 20 centers in the US and up to 200 patients for the initial evaluation.

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).


Eligibility criteria: Inclusion Criteria:

* Patients ages 6 months through 17 years of age (inclusive) at time of tympanostomy in-office using the Tula® System
* Patients who are candidates for in-office tube placement using the Tula System according to the System Instructions For Use

Exclusion Criteria:

* Patients who are wards are not included

Primary outcomes:
measure: Procedure Success
timeFrame: Day of procedure (day 0)
Secondary outcomes:
measure: Tolerability (physician reported)
timeFrame: Day of procedure (day 0)
measure: Tolerability (parent reported) - anesthesia
timeFrame: Day of procedure (day 0)
measure: Tolerability (parent reported) - procedure
timeFrame: Day of procedure (day 0)
measure: Recovery (physician reported)
timeFrame: Day of procedure (day 0)
measure: Recovery (parent reported)
timeFrame: Day of procedure (day 0)
measure: Anesthesia effectiveness - patients
timeFrame: Day of procedure (day 0)
measure: Anesthesia effectiveness - ears
timeFrame: Day of procedure (day 0)
measure: Tula Tympanostomy Tube retention
timeFrame: 1 month post procedure
measure: Parent satisfaction (informed)
timeFrame: 1 month post-procedure
measure: Parent satisfaction (siblings)
timeFrame: 1 month post-procedure
measure: Overall parent satisfaction
timeFrame: 1 month post-procedure
measure: Parent satisfaction (recommendation)
timeFrame: 1 month post-procedure
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Advanced ENT and Allergy
state: Kentucky
city: Cherry Hill
country: United States
facility: Regional Otolaryngology Head and Neck Associates
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers Robert Wood Johnson Medical School
state: New Jersey
city: New York
country: United States
facility: Columbia University Vagelos College of Physicians and Surgeons
state: New York
city: Ogden
country: United States
facility: Ogden Clinic - Professional Center North
state: Utah
city: Provo
country: United States
facility: Peak Pediatric Ear, Nose and Throat
state: Utah
Study officials:
References: