In-Office Clinical Study of the Solo+ TTD

Description

The objective of this study is to evaluate the safety and effectiveness of the Solo+ Tympanostomy Tube Device (Solo+ TTD) for the placement of tympanostomy tubes in paediatric patients undergoing a tympanostomy procedure.

Conditions

Ear Infection, Otitis Media

Talk to us

Study Overview

On this page

Study Details

Study overview

The objective of this study is to evaluate the safety and effectiveness of the Solo+ Tympanostomy Tube Device (Solo+ TTD) for the placement of tympanostomy tubes in paediatric patients undergoing a tympanostomy procedure.

Pivotal In-Office Clinical Study of the Solo+ Tympanostomy Tube Device

In-Office Clinical Study of the Solo+ TTD

Condition
Ear Infection
Intervention / Treatment

-

Contacts and Locations

Sacramento

Sacramento ENT, Sacramento, California, United States, 95661

Louisville

Advanced ENT & Allergy, Louisville, Kentucky, United States, 40220

Bethlehem

Specialty Physician Associates, Bethlehem, Pennsylvania, United States, 18017

Columbia

South Carolina ENT, Columbia, South Carolina, United States, 29203

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Patients aged ≥6 months to \<13 years
  • * Planned tympanostomy tube insertion
  • * Patient is able to commit to the follow-up visits and assessments
  • * Anatomy that precludes sufficient visualization of the tympanic membrane
  • * Anatomy that precludes safe access to the tympanic membrane and safe use of the Solo+ TTD
  • * Narrow ear canals
  • * Congenital or craniofacial abnormalities affecting the ear
  • * No baseline audiometry or tympanometry
  • * Familial history of insensitivity to anesthetic components
  • * Patient unable to remain still or is unsuitable for protective stabilization to undergo an in-office procedure

Ages Eligible for Study

6 Months to 13 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

AventaMed DAC,

Matija Daniel, STUDY_CHAIR, Queen's Medical Center

Study Record Dates

2026-06