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

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 9 months later Jul 2029 → May 2030
See other at-risk trials from AventaMed DAC

Record History

  1. Primary and study completion pushed from Jul 2029 to May 2030
    • Recruitment opened
    • Start date changed from estimate of Jul 2025 to May 21, 2026
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
AventaMed DAC
2 trials monitored
See 1 trial at risk
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.
Trial Details
NCT Number NCT07029997
Lead Sponsor AventaMed DAC
Conditions
(from sponsor)		 Otitis Media, Middle Ear Infections
Related terms Otitis Media
Enrollment 160 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov