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Biodesign Otologic graft for Ear Disease

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 canal wall mastoidectomy
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up evaluation at 6 months post-operatively
Awards & highlights

Study Summary

This study is evaluating whether a new type of graft may help heal ear canal walls following surgery.

Eligible Conditions
  • Ear Disease

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~evaluation at 6 months post-operatively
This trial's timeline: 3 weeks for screening, Varies for treatment, and evaluation at 6 months post-operatively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Epithelialization of the canal wall down mastoid cavity
Secondary outcome measures
Audio-metric outcome
Determination of dry cavity

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Biodesign Otologic GraftExperimental Treatment1 Intervention
Graft following canal wall down mastoidectomy.
Group II: Autograft temporalis fasciaActive Control1 Intervention
Graft following canal wall down mastoidectomy.

Find a Location

Who is running the clinical trial?

Ascension South East MichiganLead Sponsor
18 Previous Clinical Trials
33,190 Total Patients Enrolled
Seilesh Babu, MDPrincipal InvestigatorPhysician of record
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.
Recent research and studies
clinicaltrials.govStudy
Use of Biodesign® Otologic Graft in Canal Wall Down Mastoidectomy: A Prospective, Randomized Trial
2018. "Use of Biodesign® Otologic Graft in Canal Wall Down Mastoidectomy: A Prospective, Randomized Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03902938.
~0 spots leftby Apr 2025
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