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NCT05849844 · ClinicalTrials.gov registry record · NA
Tympanoseal Clinical Study
A NA study of Tympanic Membrane Perforation, sponsored by Grace Medical.
- Recruiting
- Registry status
- NA
- Development phase
- 45
- Enrollment target
- 2
- Study locations
NCT05849844: Recruiting NA study of Tympanic Membrane Perforation, sponsored by Grace Medical.
NCT05849844 is a NA study of Tympanic Membrane Perforation that is actively recruiting participants, run by Grace Medical. The registered enrollment target is 45 participants, below the 155-participant average among 3 other Tympanic Membrane Perforation trials with a reported enrollment target (71% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05849844, a NA study of Tympanic Membrane Perforation, is actively recruiting participants, sponsored by Grace Medical.
- RECRUITING
- Registry status
- NA
- Development phase
- 45 participants
- Enrollment target
- 2
- Study locations
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.
Primary Outcome
The purpose of this investigational study is to assess the safety of Tympanoseal when used during the healing process. Subject will be observed during the study and the the healing process of the tympanic membrane. Information will be gathered via report forms during regular visits of the patient to the investigator.
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 |
What NCT05849844 shows while recruiting
NCT05849844 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 155-participant average among 3 other Tympanic Membrane Perforation trials with a reported enrollment target (71% lower).
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.
NCT05849844 reports a single indexed study location in Michigan, Tennessee.
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.
What interventions are being tested in trial NCT05849844?
The interventions under investigation include: Tympanoseal (DEVICE).
Who is sponsoring clinical trial NCT05849844?
This trial is sponsored by Grace Medical, which has 2 total clinical trials registered on ClinicalTrials.gov.
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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