Tympanoseal Clinical Study

Part of paid clinical trials in Farmington Hills, Michigan.

Sponsor
Grace Medical, Inc.
Study ID
NCT05849844
Status
Recruiting
Apply to this trial

Conditions

  • Tympanic Membrane Perforation

Eligibility Criteria

Sex
ALL
Age
2 Years - 100 Years
Healthy Volunteers
Accepted

Interventions

  • Tympanoseal — DEVICE
    All subjects will receive the Tympanoseal device that will be placed during a surgical procedure

Study Details

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.

Key Dates

Start date
Jan 5, 2024
Status verified
Oct 2024
Primary completion
Apr 20, 2026
Completion
Apr 20, 2026

Study Design

Enrollment
45 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Tympanoseal
    All subjects will receive the Tympanoseal device that will be placed during a surgical procedure.

Primary Outcome Measure

Number of participants with healed tympanic membrane perforations. [ Time Frame: 12 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Michigan Ear InstituteFarmington HillsMichigan48334
Seilesh Babu, MD
[email protected]
248-865-4135
Robert Stroup
[email protected]
6623970553
Seilesh Babu, MD (PRINCIPAL_INVESTIGATOR)
Methodist Le BonheurMemphisTennessee38103
Robert Yawn, MD
[email protected]
901-287-7337

Find similar trials in Farmington Hills, MI

By research site
Michigan Ear Institute· Farmington Hills, MIMethodist Le Bonheur· Memphis, TN