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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up anticipated 18 months
Awards & highlights
Summary
This is a retrospective chart review performed at multiple clinics aimed at providing real-world evidence of the use and safety of the P4HB scaffold. Data on patient demographics, relevant medical history, product and procedure used, product safety, and outcome measures will be collected as available.
Eligible Conditions
- Plastic Surgery
- Reconstructive Surgery
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ anticipated 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~anticipated 18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Real-world utilization of P4HB scaffold
Secondary outcome measures
Surgeon/patient satisfaction
Other outcome measures
Follow up visits
Safety - adverse and serious adverse events
Use of Product
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Who is running the clinical trial?
C. R. BardLead Sponsor
103 Previous Clinical Trials
38,417 Total Patients Enrolled
Tepha, Inc.Industry Sponsor
2 Previous Clinical Trials
84 Total Patients Enrolled
K McGinnisStudy DirectorTepha, Inc/Galatea Surgical
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