In-Office Clinical Study of the Solo+ TTD

Last updated: April 15, 2025
Sponsor: AventaMed DAC
Overall Status: Active - Recruiting

Phase

N/A

Condition

Ear Infections (Pediatric)

Otitis Media

Otitis Externa (Swimmer's Ear)

Treatment

Solo+ Tympanostomy Tube Device (Solo+ TTD)

Clinical Study ID

NCT05741333
CSP003
  • Ages 6-13
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients aged ≥6 months to <13 years

  • Planned tympanostomy tube insertion

  • Patient is able to commit to the follow-up visits and assessments

Exclusion

Exclusion Criteria:

  • Anatomy that precludes sufficient visualization of the tympanic membrane

  • Anatomy that precludes safe access to the tympanic membrane and safe use of theSolo+ 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 toundergo an in-office procedure

Study Design

Total Participants: 66
Treatment Group(s): 1
Primary Treatment: Solo+ Tympanostomy Tube Device (Solo+ TTD)
Phase:
Study Start date:
March 30, 2023
Estimated Completion Date:
June 30, 2027

Study Description

The study will be a multi-site, prospective, treatment-only study to gather safety and effectiveness data on the use of the Solo+ TTD in-office with topical anesthesia in children aged ≥6 months to <13 years.

Connect with a study center

  • Southern Head & Neck Surgery

    Alexander City, Alabama 35010
    United States

    Active - Recruiting

  • North Alabama ENT

    Huntsville, Alabama 35801
    United States

    Active - Recruiting

  • East Alabama ENT

    Opelika, Alabama 36801
    United States

    Active - Recruiting

  • Sacramento ENT

    Sacramento, California 95661
    United States

    Site Not Available

  • Advanced ENT & Allergy

    Louisville, Kentucky 40220
    United States

    Site Not Available

  • Specialty Physician Associates

    Bethlehem, Pennsylvania 18017
    United States

    Site Not Available

  • South Carolina ENT

    Columbia, South Carolina 29203
    United States

    Site Not Available

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