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Tympanoseal Clinical Study

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated October 15, 2024 (before its estimated April 20, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Study sites: 1 to 2v6
  2. Lead sponsor: [Redacted] to Grace Medical, Inc.v5 Show 4 more changesShow less
    • Trial status: Withheld to Recruiting
    • Primary and study completion dates: Apr 20, 2026
    • Start date: Jan 5, 2024
    • Study title shortened, about 10 words
  3. 3 versions Re-verified since Sep 11, 2023, no change to tracked fieldsv2-v4
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of this investigational study is to assess the ability of Tympanoseal (sodium/calcium alginate), an investigational device, to act as a scaffold during healing of the tympanic membrane. Tympanoseal is intended for use following removal or extrusion of indwelling tympanostomy tubes or traumatic injury of the tympanic membrane.
Trial Details
NCT Number NCT05849844
Lead Sponsor Grace Medical, Inc.
Conditions
(from sponsor)		 Tympanic Membrane Perforation
Related terms Tympanic Membrane Perforation
Enrollment 45 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov