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Extracellular Matrix Graft
Biodesign Otologic graft for Ear Drum Perforation
Phase 4
Waitlist Available
Led By Seilesh Babu, MD
Research Sponsored by Ascension South East Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients undergoing primary tympanoplasty without mastoidectomy.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months postoperatively by the surgeon
Awards & highlights
Study Summary
This study is evaluating whether a new type of graft may help improve outcomes for individuals who have had surgery to repair their eardrum.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months postoperatively by the surgeon
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months postoperatively by the surgeon
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Assessment of graft take after tympanoplasty
Secondary outcome measures
Measurement of Hearing Parameters
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Biodesign graft tympanic membrane repairExperimental Treatment1 Intervention
Patient's perforated tympanic membrane will be repaired with an acellular matrix derived from porcine small intestine submucosa, Biodesign Otologic graft
Group II: Autograft tympanic membrane repairActive Control1 Intervention
Patient's perforated tympanic membrane will be repaired with autologous temporalis fascia.
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Who is running the clinical trial?
Ascension South East MichiganLead Sponsor
18 Previous Clinical Trials
33,190 Total Patients Enrolled
Seilesh Babu, MDPrincipal InvestigatorMichigan Ear Institute
2 Previous Clinical Trials
17 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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