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Clinical Study of the Solo+ Tympanostomy Tube Device

NCT04148417 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2024-01-24

No results posted yet for this study

Summary

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

Conditions

  • Ear Infection
  • Otitis Media

Interventions

DEVICE

Solo+ Tympanostomy Tube Device

The Solo+ Tympanostomy Tube Device is intended to deliver a tympanostomy tube through the tympanic membrane of a patient during a tympanostomy procedure

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
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-09
Primary Completion
2024-09-30
Completion
2024-09-30
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 NCT04148417 on ClinicalTrials.gov