In-Office Clinical Study of the Solo+ TTD (VENTY)

March 31, 2026 updated by: AventaMed DAC

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Alexander City, Alabama, United States, 35010
        • Southern Head & Neck Surgery
      • Huntsville, Alabama, United States, 35801
        • North Alabama ENT
      • Opelika, Alabama, United States, 36801
        • East Alabama ENT
    • California
      • Sacramento, California, United States, 95661
        • Sacramento ENT
    • Kentucky
      • Louisville, Kentucky, United States, 40220
        • Advanced ENT & Allergy
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18017
        • Specialty Physician Associates
    • South Carolina
      • Columbia, South Carolina, United States, 29203
        • South Carolina ENT

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.

Eligibility Criteria

Ages Eligible for Study

6 months to 13 years (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Solo+ Tympanostomy Tube Device (Solo+ TTD)
The Solo+ TTD is a disposable surgical tool designed to deliver a tympanostomy tube into the tympanic membrane of patients undergoing a tympanostomy tube placement procedure.
Device: Solo+ Tympanostomy Tube Device (Solo+ TTD)
The Solo+ TTD is intended to deliver a tympanostomy tube through the tympanic membrane of a patient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedure Success
Time Frame: Intra-operative
Percentage of subjects in which the Solo+ TTD tympanostomy tube is inserted in all indicated ears
Intra-operative
Rate of Adverse Events
Time Frame: 24 months
Incidence and nature of device- or procedure-related adverse events
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AventaMed DAC

Investigators

  • Study Chair: Matija Daniel, Queen's Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2023

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

February 14, 2023

First Submitted That Met QC Criteria

February 14, 2023

First Posted (Actual)

February 23, 2023

Study Record Updates

Last Update Posted (Actual)

April 1, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSP003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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