Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05741333

In-Office Clinical Study of the Solo+ TTD

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Ear Infection Ear Diseases Otitis Otitis Media Otorhinolaryngologic Diseases

Age range

6 month–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Southern Head & Neck Surgery, Alexander City, Alabama, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 criteria

  • 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

Treatment and study plan

Solo+ Tympanostomy Tube Device (Solo+ TTD)

Device

The Solo+ TTD is intended to deliver a tympanostomy tube through the tympanic membrane of a patient.

Primary outcomes

  1. Procedure Success

    Time frame: Intra-operative

    Percentage of subjects in which the Solo+ TTD tympanostomy tube is inserted in all indicated ears

  2. Rate of Adverse Events

    Time frame: 24 months

    Incidence and nature of device- or procedure-related adverse events

Sponsors and collaborators

Lead sponsor

AventaMed DAC

Industry

Registry information

Official study title

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

Acronym: VENTY

Important dates

Study start
2023
Primary completion
2026
Study completion
2028
First posted
Feb 23, 2023
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.