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Otitis Media With EffusionNCT05915078

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

An observational study of Otitis Media With Effusion and Acute Otitis Media, run by Smith & Nephew, Inc. at 6 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 months to 17 years
What is being tested?
Iontophoresis and tube placement
How many people
200 participants
Where
6 sitesUnited States
Study dates
15 Jun 2023to 30 Jun 2027
How long will I take part?
2 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 months to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: Participating centers will invite eligible patients ages 6 months to 17 years of age indicated for tympanostomy to participate in the Registry

Who may be able to join

  • 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

Who cannot join

  • Patients who are wards are not included

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Catherine E Whittall, BsC, Ph.D contact

+44 7841 868997

catherine.whittall@smith-nephew.com

6 sites in 1 country

United States6 sites, 6 recruiting

  • Regional Otolaryngology Head and Neck Associates

    Cherry Hill, New Jersey, 08034

    Megan Morgan

    Ryan D Walker, MD

    Recruiting

  • Advanced ENT and Allergy

    Louisville, Kentucky, 40220

    Jennifer Leonard, 502-893-0159 ext. 1185, jleonard@advancedentandallergy.com

    Colin A Neumann, MD

    Recruiting

  • Rutgers Robert Wood Johnson Medical School

    New Brunswick, New Jersey, 08901

    Kelvin M Kwong

    Kelvin M Kwong, MD

    Recruiting

  • Columbia University Vagelos College of Physicians and Surgeons

    New York, New York, 10032

    Lawrence Lustig, MD

    Recruiting

  • Ogden Clinic - Professional Center North

    Ogden, Utah, 84403

    Ashley Erickson

    Douglas K Anderson, MD

    Recruiting

  • Peak Pediatric Ear, Nose and Throat

    Provo, Utah, 84604

    Jordan C Schramm

    Jordan C Schramm, MD

    Recruiting

Other trials in United States

About this study

Official title: Evaluation of Clinical and Health Economic 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).

Being tested
Iontophoresis and tube placement
Keywords
Otitis media, pediatric, tympanostomy, office procedure, local anesthesia
Medical subject headings
Otitis Media with Effusion, Otitis Media

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Iontophoresis and tube placementCombination product

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

Study groups in NCT05915078
Study groupRoleWhat they receive
Tula TympanostomyPatients undergoing in-office tympanostomy using the Tula® System
Receives: Combination Product: Iontophoresis and tube placement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Procedure Success

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

    Measured: Day of procedure (day 0)

Secondary outcomes (12)

  1. Tolerability (physician reported)

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

    Measured: Day of procedure (day 0)

  2. Tolerability (parent reported) - anesthesia

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

    Measured: Day of procedure (day 0)

  3. Tolerability (parent reported) - procedure

    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'.

    Measured: Day of procedure (day 0)

  4. Recovery (physician reported)

    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.

    Measured: Day of procedure (day 0)

  5. Recovery (parent reported)

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

    Measured: Day of procedure (day 0)

  6. Anesthesia effectiveness - patients

    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

    Measured: Day of procedure (day 0)

  7. Anesthesia effectiveness - ears

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

    Measured: Day of procedure (day 0)

  8. Tula Tympanostomy Tube retention

    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

    Measured: 1 month post procedure

  9. Parent satisfaction (informed)

    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'

    Measured: 1 month post-procedure

  10. Parent satisfaction (siblings)

    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'

    Measured: 1 month post-procedure

  11. Overall parent satisfaction

    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'

    Measured: 1 month post-procedure

  12. Parent satisfaction (recommendation)

    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'

    Measured: 1 month post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2023
  2. Study start15 Jun 2023
  3. Primary completion30 Mar 2025 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
200 participants (estimated)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT05915078
Sponsor's protocol ID
Tula Registry
Status last verified
Jul 2024
First submitted
13 Jun 2023
Last updated
23 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Otitis Media With Effusion and Acute Otitis Media, run by Smith & Nephew, Inc. at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Catherine E Whittall, BsC, Ph.D (+44 7841 868997, catherine.whittall@smith-nephew.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Procedure Success (time frame: Day of procedure (day 0)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05915078.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2024.

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