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Post-Market Clinical Follow-Up Study of the Solo+ Tympanostomy Tube Device

NCT07029997 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 160

Last updated 2025-06-19

No results posted yet for this study

Summary

The purpose of this project is to collect information from the doctor notes about the use of the device, to monitor the tubes after surgery, and collect information from patients and parents/guardians about their views on the procedure. Since the device became available in Europe, it is important to collect information from both patients planned for the procedure (prospective) and those who already underwent the procedure (retrospective) to have collect as much data as possible.

Conditions

  • Otitis Media
  • Middle Ear Infections

Interventions

DEVICE

Solo+ Tympanostomy Tube Device (Solo+ TTD)

insertion of eartubes

Sponsors & Collaborators

  • AventaMed DAC

    lead INDUSTRY

Eligibility

Min Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-31
Primary Completion
2029-07-31
Completion
2029-07-31

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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 NCT07029997 on ClinicalTrials.gov