NCT05849844

Tympanoseal Clinical Study

Tympanoseal (Tympanic Membrane Device) Clinical Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Grace Medical, Inc. · Industry
• Sex: All
• Age: 2 Years – 100 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Tympanic Membrane Perforation

Interventions

Type	Name	Description
DEVICE	Tympanoseal	All subjects will receive the Tympanoseal device that will be placed during a surgical procedure

Timeline

• Start date: 2024-01-05
• Primary completion: 2026-04-20
• Completion: 2026-04-20
• First posted: 2023-05-09
• Last updated: 2024-10-15

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study