In-Office Tympanostomy Tube Placement in Children (OTTER)

NCT03323736 | Completed Phase 3 Results FDA Drug FDA Device

• 1 other identifier: CPR007001
• Study Type: interventional
• Target: 370
• Locations: 2 countries
• Sites: 19

Brief Summary

A prospective, single-arm, multicenter study to evaluate effectiveness and safety of Tymbion iontophoresis and tympanostomy tube placement using the Tula Iontophoresis and Tube Delivery Systems for children in an office setting.

Conditions

OME - Otitis Media With Effusion; AOM - Acute Otitis Media

Outcome Measures

Primary Outcomes (2)

• Procedural Success:

  Count (and percentage) of subjects in the pivotal cohort with successful placement of Tusker Medical tympanostomy tubes in all indicated ears in an office procedure. Note: the primary endpoint applies only to the Pivotal Cohort, and not to the OR Lead-In or Office Lead-In cohorts.

  Day of Procedure (Day 0) Immediately following tube placement

• Tube Placement Tolerability

  Mean subject-reported pain score following TDS tube placement using the Faces Pain Scale-Revised (FPS-R) (pivotal cohort children ages 5 and older only). The FPS-R has 6 faces which permits scaling to a 0-to-10 scoring system in intervals of 2 (ie 0, 2, 4, 6, 8 and 10), where 0 represents 'no pain' and 10 represents 'very much pain'. Note- the primary endpoint applies only to the Pivotal Cohort, and not to the OR Lead-In or Office Lead-In cohorts.

  Day of Procedure (Day 0) Immediately following tube placement

Secondary Outcomes (3)

• Tube Patency

  3 Weeks Post Procedure

• Tube Retention

  3 Weeks Post Procedure

• Anesthesia Effectiveness

  Day of Procedure (Day 0)

Study Arms (3)

Pivotal Cohort

OTHER

Active Tymbion iontophoresis and tube insertion using the Tube Delivery System in-office.

Combination Product: Iontophoresis & tube placement

Office Lead-In Cohort

OTHER

Active Tymbion iontophoresis and tube insertion using the Tube Delivery System in-office. Physician initial in-office iontophoresis and tube insertion procedures (minimum of 2 subjects per investigator).

Combination Product: Iontophoresis & tube placement

OR Lead-In Cohort

OTHER

Tubes insertion using the Tube Delivery System in the operating room (OR). Physician initial tube insertion procedures in the OR (minimum of 2 subjects per investigator).

Device: Tube placement

Interventions

Iontophoresis & tube placement COMBINATION_PRODUCT

Subjects will receive active Tymbion iontophoresis and will have tubes placed in-office using the Tube Delivery System in all ears indicated for tube placement.

Office Lead-In Cohort; Pivotal Cohort

Tube placement DEVICE

Subjects will have tubes placed in the OR using the Tube Delivery System in all ears indicated for tube placement.

OR Lead-In Cohort

Eligibility Criteria

• Age: 6 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Males or females at least 6 months old through 12 years old at time of consent
• Indication for tympanostomy tube insertion per Clinical Practice Guideline
• Behavioral capacity and cooperative temperament to undergo an awake procedure, based on physician judgment (not applicable to OR Lead-In subjects)
• Subject's parent/guardian and subject are able and willing to comply with the protocol and attend all study visits
• Subject's parent/guardian and subject are able and willing to provide informed consent or assent as age appropriate

You may not qualify if:

• Significantly atrophic, retracted, bimeric, monomeric or atelectatic tympanic membrane
• Perforated tympanic membrane
• Otitis externa
• Active or recent conditions of the tympanic membrane (eg, prior myringotomy with incomplete wound healing or re-epithelization)
• Hemotympanum
• Damaged/denuded skin in the auditory canal
• Cerumen impaction resulting in a significant amount of cleaning required to visualize the tympanic membrane potentially causing abrasion or irritation to the external ear canal
• Anatomy that precludes sufficient visualization of and access to the tympanic membrane
• Anatomy that necessitates tympanostomy tube placement in the posterior half of the tympanic membrane
• History of sensitivity or allergic reaction to lidocaine HCl, tetracaine, epinephrine, or any hypersensitivity to local anesthetics of the amide type, or any component of the anesthetic drug formulation (not applicable to OR Lead-In subjects)
• Familial history of insensitivity to lidocaine or other local anesthetics of the amide type (eg, history of inadequate anesthesia with dental numbing agents). (not applicable to OR Lead-In subjects)
• Electrically sensitive medical support systems (eg, pacemakers, defibrillators, cochlear implants)
• Other conditions that would preclude performing the study procedure including iontophoresis system ear plug incompatibility.
• Health conditions that, in the opinion of the investigator, would present undue risk to the subject, based on device/anesthetic drug product label warnings and precautions.
• Subject is 4 years or older and not able to complete all baseline assessments. Subject is younger than 4 years and not able to complete all baseline assessments, not including audiometry.

Sponsors & Collaborators

• Tusker Medical: lead

Study Sites (19)

California Head and Neck Specialists

Carlsbad, California, 92008, United States

Location

Sacramento ENT

Roseville, California, 95661, United States

Location

Camino Ear Nose & Throat Clinic

San Jose, California, 95138, United States

Location

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

Location

Yale School of Medicine, Section of Otolaryngology

New Haven, Connecticut, 06510, United States

Location

South Florida Pediatric Otolaryngology

Fort Lauderdale, Florida, 33316, United States

Location

Nemour's Children's Specialty Care

Jacksonville, Florida, 32207, United States

Location

Advanced ENT & Allergy

Louisville, Kentucky, 40207, United States

Location

Albany ENT & Allergy Services

Albany, New York, 12206, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Charlotte Ear Eye Nose & Throat Associates, PA

Charlotte, North Carolina, 28105, United States

Location

Specialty Physician Associates

Bethlehem, Pennsylvania, 18017, United States

Location

South Carolina Ear Nose and Throat

Lugoff, South Carolina, 29078, United States

Location

Carolina Ear Nose and Throat Clinic

Orangeburg, South Carolina, 29118, United States

Location

Ear Nose and Throat Specialists of Abilene

Abilene, Texas, 79601, United States

Location

Frisco ENT for Children

Frisco, Texas, 75033, United States

Location

Collin County ENT

Frisco, Texas, 75034, United States

Location

Ear Medical Group

San Antonio, Texas, 78240, United States

Location

British Columbia Children's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

Location

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

Results Point of Contact

• Title: Laura England, PhD
• Organization: Smith+Nephew

laura.england@smith-nephew.com

(650) 223-6909

Study Officials

• Lawrence Lustig

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Pivotal cohort is single arm. Physician initial subjects evaluated in separate cohorts but not included in primary and secondary analyses.

Study Record Dates

• First Submitted: October 24, 2017
• First Posted: October 27, 2017
• Study Start: October 31, 2017
• Primary Completion: February 28, 2019
• Study Completion: March 25, 2021
• Last Updated: May 26, 2022
• Results First Posted: January 31, 2020

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (18)