MedTrace Logo

In-Office Tympanostomy Tube Placement in Children (OTTER)

NCT03323736 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 370

Last updated 2022-05-26

Study results available
· View outcomes & findings →

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

Interventions

COMBINATION_PRODUCT

Iontophoresis & tube placement

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.

DEVICE

Tube placement

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

Sponsors & Collaborators

  • Tusker Medical

    lead INDUSTRY

Principal Investigators

  • Lawrence Lustig · Columbia University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-31
Primary Completion
2019-02-28
Completion
2021-03-25
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03323736 on ClinicalTrials.gov