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In-Office Clinical Study of the Solo+ TTD

NCT05741333 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2026-04-01

No results posted yet for this 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.

Conditions

  • Ear Infection
  • Otitis Media

Interventions

DEVICE

Solo+ Tympanostomy Tube Device (Solo+ TTD)

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

Sponsors & Collaborators

  • AventaMed DAC

    lead INDUSTRY

Principal Investigators

  • Matija Daniel · Queen's Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2023-03-30
Primary Completion
2026-05-31
Completion
2028-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT05741333 on ClinicalTrials.gov