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

NCT05915078 | Recruiting FDA Drug FDA Device

• 1 other identifier: Tula Registry
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 6

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).

Conditions

Otitis Media With Effusion; Acute Otitis Media; Otitis Media

Keywords

Otitis media; pediatric; tympanostomy; office procedure; local anesthesia

Outcome Measures

Primary Outcomes (1)

• Procedure Success

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

  Day of procedure (day 0)

Secondary Outcomes (12)

• Tolerability (physician reported)

  Day of procedure (day 0)

• Tolerability (parent reported) - anesthesia

  Day of procedure (day 0)

• Tolerability (parent reported) - procedure

  Day of procedure (day 0)

• Recovery (physician reported)

  Day of procedure (day 0)

• Recovery (parent reported)

  Day of procedure (day 0)

Study Arms (1)

Tula Tympanostomy

Patients undergoing in-office tympanostomy using the Tula® System

Combination Product: Iontophoresis and tube placement

Interventions

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

Tula Tympanostomy

Eligibility Criteria

• Age: 6 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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

You may not qualify if:

• Patients who are wards are not included

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (6)

Advanced ENT and Allergy

Louisville, Kentucky, 40220, United States

RECRUITING

Regional Otolaryngology Head and Neck Associates

Cherry Hill, New Jersey, 08034, United States

RECRUITING

Rutgers Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States

RECRUITING

Columbia University Vagelos College of Physicians and Surgeons

New York, New York, 10032, United States

RECRUITING

Ogden Clinic - Professional Center North

Ogden, Utah, 84403, United States

RECRUITING

Peak Pediatric Ear, Nose and Throat

Provo, Utah, 84604, United States

RECRUITING

MeSH Terms

Conditions

Otitis Media with Effusion; Otitis Media

Interventions

Iontophoresis

Condition Hierarchy (Ancestors)

Otitis; Ear Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Electrophoresis; Electrochemical Techniques; Investigative Techniques

Central Study Contacts

Catherine E Whittall, BsC, Ph.D

CONTACT

+44 7841 868997; catherine.whittall@smith-nephew.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2023
• First Posted: June 22, 2023
• Study Start: June 15, 2023
• Primary Completion: March 30, 2025
• Study Completion (Estimated): June 30, 2027
• Last Updated: July 23, 2024

Record last verified: 2024-07

Locations

US (6)