Tympanoseal Clinical Study

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

This study will provide data on the safety and the ability of sodium/calcium alginate gels to act as a scaffold capable of occluding a tympanic membrane perforation over the duration of complete healing. Tympanoseal could be used in cases where cartilage or fat graft tympanoplasty would be indicated. ;

Study Design

Related Conditions & MeSH terms

Tympanic Membrane Perforation

Clinical Trial Details

NCT number	NCT05849844
Study type	Interventional
Source	Grace Medical, Inc.
Contact	Robert Stroup
Phone	901-386-0990
Email	robert.stroup@gracemedical.com
Status	Recruiting
Phase	N/A
Start date	January 5, 2024
Completion date	April 20, 2026

View Details

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