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Extracellular Matrix Graft
Use of Biodesign® Otologic Graft in Tympanoplasty
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
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This is a prospective, randomized trial to evaluate tympanoplasty outcomes using Biodesign SIS graft compared to autologous temporalis fascia, the most commonly used graft for repair of tympanic membrane.
Eligible Conditions
- Ear Perforation
- Ear Drum Perforation
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Assessment of graft take after tympanoplasty
Secondary study objectives
Measurement of Hearing Parameters
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Find a Location
Who is running the clinical trial?
Ascension South East MichiganLead Sponsor
18 Previous Clinical Trials
32,423 Total Patients Enrolled
Seilesh Babu, MDPrincipal InvestigatorMichigan Ear Institute
2 Previous Clinical Trials
17 Total Patients Enrolled