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Tympanoseal Clinical Study
NCT05849844 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DEVICE Tympanoseal
Study Locations (2)
Michigan
- Michigan Ear Institute — Farmington Hills
Tennessee
- Methodist Le Bonheur — Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2024-01-05 |
| Est. Completion | 2026-04-20 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05849844
The ClinicalTrials.gov registry entry for NCT05849844 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Grace Medical, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Tympanic Membrane Perforation appearing as the primary indexed condition, and to 1 intervention — of which Tympanoseal is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05849844 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Michigan, Tennessee. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05849844 about?
NCT05849844 is a clinical study titled "Tympanoseal Clinical Study". 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 tra...
What is the current status of trial NCT05849844?
This trial is currently recruiting. It is a NA study. The enrollment target is 45 participants. The study started on 2024-01-05. Estimated completion is 2026-04-20.
What conditions does trial NCT05849844 study?
This clinical trial studies the following conditions: Tympanic Membrane Perforation. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05849844?
The interventions under investigation include: Tympanoseal (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05849844?
This trial is sponsored by Grace Medical, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05849844 being conducted?
This trial has 2 study locations across Michigan, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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