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NCT Number: NCT05915078

Evaluation of Outcomes Following In-office Tympanostomy Using the Tula® System: a Prospective, Multi-center Registry

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).

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Key information

Conditions

OTITIS MEDIA WITH EFFUSION Acute Otitis Media Ear Diseases Otitis Otitis Media Otorhinolaryngologic Diseases

Age range

6 month–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Advanced ENT and Allergy, Louisville, Kentucky, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Iontophoresis and tube placement

Combination Product

Iontophoretic delivery of TYMBION™ otic anesthetic using the Tula Iontophoresis System and tube insertion using the Tula Tube Delivery System

Primary outcomes

  1. Procedure Success

    Time frame: Day of procedure (day 0)

    Count (and percentage) of patients with successful placement of Tula Tympanostomy Tubes in all indicated ears in an office procedure

Secondary outcomes

  1. Tolerability (physician reported)

    Time frame: Day of procedure (day 0)

    Count (and percentage) of patients that tolerated the procedure acceptably as determined by physician's observation.

  2. Tolerability (parent reported) - anesthesia

    Time frame: Day of procedure (day 0)

    Count (and percentage) of patients whose parents strongly agree or agree with the statement 'My child tolerated the anesthesia process well'

  3. Tolerability (parent reported) - procedure

    Time frame: Day of procedure (day 0)

    Count (and percentage) of patients whose parents strongly agree or agree with the statement 'The tube placement portion of the procedure was tolerable for my child'.

  4. Recovery (physician reported)

    Time frame: Day of procedure (day 0)

    Count (and percentage) of patients who recovered once back with parent, or prior to leaving the clinic, following procedure completion as determined by physician's observation.

  5. Recovery (parent reported)

    Time frame: Day of procedure (day 0)

    Count (and percentage) of patients who returned to normal activities immediately following the procedure.

  6. Anesthesia effectiveness - patients

    Time frame: Day of procedure (day 0)

    Count (and percentage) of patients who completed iontophoresis with adequate anesthesia for tube placement in all treated ears as determined by the physician's evaluation of tympanic membrane anesthesia

  7. Anesthesia effectiveness - ears

    Time frame: Day of procedure (day 0)

    Count (and percentage) of ears that completed iontophoresis with adequate anesthesia for TT placement as determined by the physician's tympanic membrane anesthesia evaluation.

  8. Tula Tympanostomy Tube retention

    Time frame: 1 month post procedure

    Count (and percentage) of patients at the first post-operative visit in which a Tula Tympanostomy Tube was successfully placed, with presence of the Tula Tympanostomy Tube across the tympanic membrane

  9. Parent satisfaction (informed)

    Time frame: 1 month post-procedure

    Count (and percentage) of patients whose parents strongly agree or agree with the survey question:

    'I felt well informed and prepared to help me/my child complete the procedure'

  10. Parent satisfaction (siblings)

    Time frame: 1 month post-procedure

    Count (and percentage) of patients whose parents strongly agree or agree with the survey question:

    'If my child had a sibling who needed ear tubes, I would choose this procedure in the office instead of going under general anesthesia in the operating room'

  11. Overall parent satisfaction

    Time frame: 1 month post-procedure

    Count (and percentage) of patients whose parents strongly agree or agree with the survey question:

    'Overall, I am very satisfied with the in-office ear tube procedure'

  12. Parent satisfaction (recommendation)

    Time frame: 1 month post-procedure

    Count (and percentage) of patients whose parents strongly agree or agree with the survey question:

    'I would recommend this procedure to family/friends who have children who need ear tubes'

Study contacts

Contact information is provided by the study sponsor or research team.

Catherine E Whittall, BsC, Ph.D

CONTACT

[email protected]

+44 7841 868997

Sponsors and collaborators

Lead sponsor

Smith & Nephew, Inc.

Industry

Registry information

Official study title

Evaluation of Clinical and Health Economic Outcomes Following In-office Tympanostomy Using the Tula® System: a Prospective, Multi-center Registry

Important dates

Study start
2023
Primary completion
2025
Study completion
2027
First posted
Jun 22, 2023
Registry last updated
Jul 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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