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NCT02918942 · ClinicalTrials.gov registry record
Tympanoseal (Tympanic Membrane Device) Clinical Study
A clinical trial, sponsored by Grace Medical.
- Completed
- Registry status
- 25
- Enrollment target
NCT02918942: Completed study, sponsored by Grace Medical.
NCT02918942 is a clinical trial that has completed, run by Grace Medical. The registered enrollment target is 25 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02918942 has completed, sponsored by Grace Medical.
- COMPLETED
- Registry status
- 25 participants
- Enrollment target
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 healing process of the tympanic membrane. Information will be gathered via report forms during regular visits of the patient to the investigator. Any serious adverse events (SAE) will be noted. An SAE is defined as any adverse event occurring that results in any of the following outcomes: 1. Death 2. A life-threatening adverse
Interventions
- DEVICE Tympanoseal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2016-10-04 |
| Est. Completion | 2021-09-30 |
What the finished NCT02918942 record still lists
NCT02918942 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Tympanoseal is the first listed.
NCT02918942 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02918942 about?
NCT02918942 is a clinical study titled "Tympanoseal (Tympanic Membrane Device) 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 NCT02918942?
This trial is currently completed. The enrollment target is 25 participants. The study started on 2016-10-04. Estimated completion is 2021-09-30.
What interventions are being tested in trial NCT02918942?
The interventions under investigation include: Tympanoseal (DEVICE).
Who is sponsoring clinical trial NCT02918942?
This trial is sponsored by Grace Medical, which has 2 total clinical trials registered on ClinicalTrials.gov.
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