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Tympanoseal Clinical Study

Grace Medical, Inc. · NCT05849844

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 2–100 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
45
US sites recruiting
2
Study start
January 5, 2024
Record last updated
October 15, 2024

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Tympanoseal

Conditions: Tympanic Membrane Perforation

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • Male or female patients over 2 years of age at enrollment
  • Documentation of a retained tympanostomy tube or perforation less than 5 mm not on the edge of the tympanic membrane.
  • Written informed consent (and assent when applicable) obtained from subject or subject's legal guardian and ability for subject to comply with the requirements of the study

Exclusion Criteria

  • Active otorrhea or otitis media
  • Otorrhea or otitis media within 4 weeks prior to the operation
  • History of cholesteatoma
  • Perforations on the edge of the tympanic membrane
  • Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
  • Subject is taking systemic/oral corticosteroids
  • Subject will require the continued use of any type of topical otic medication to the ear(s) with Tympanoseal

Recruiting US locations

  • Michigan Ear Institute

    Farmington Hills, MI 48334

    Site contact: Seilesh Babu, MD · 248-865-4135 · sbabu04@gmail.com

  • Methodist Le Bonheur

    Memphis, TN 38103

    Site contact: Robert Yawn, MD · 901-287-7337 · ryawn@uthsc.edu

Study contacts (from the official record)

  • Robert Stroup · 901-386-0990 · robert.stroup@gracemedical.com
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Tympanoseal Clinical Study (NCT05849844) | Bored Studies