Status:
TERMINATED
Use of Human Dehydrated Amnion Chorion Allograft in Laryngectomy/Pharyngectomy
Lead Sponsor:
MiMedx Group, Inc.
Conditions:
Larynx Cancer
Pharynx Cancer
Eligibility:
All Genders
18+ years
Brief Summary
This trial aims to determine if intra-operative use of human dehydrated amnion chorion allograft improves post-operative patient healing outcomes.
Detailed Description
This study is to determine if intra-operative use of Amnio-Fix improves post-operative patient healing outcomes after laryngectomy and/or pharyngectomy.
Eligibility Criteria
Inclusion
- Subject is scheduled to undergo laryngectomy and/or pharyngectomy procedure due to oncological indication
- Subject is age 18 or older
- Subject is willing and able to provide informed consent and participate in all procedures and follow-up evaluations necessary to complete the study
Exclusion
- Subjects currently enrolled in or planning to enroll in another clinical trial
- Subjects with a known history of poor compliance with medical treatments
- Subjects that are using or have used an investigational drug, device, or biologic within the 12 weeks prior to treatment
- Subjects that have any significant medical condition(s) that, in the opinion of the Investigator, would interfere with protocol evaluation and participation
- Subject has undergone previous pharyngeal reconstructive surgery
- Pregnancy at enrollment or within last 6 months, women who are breastfeeding, or women of childbearing potential who are planning to become pregnant during the time of the study OR are unwilling/unable to use acceptable methods of contraception (birth control pills, barriers, or abstinence)
Key Trial Info
Start Date :
March 19 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 30 2019
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT03479463
Start Date
March 19 2018
End Date
March 30 2019
Last Update
November 13 2020
Active Locations (1)
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1
Mount Sinai Hospital
New York, New York, United States, 10029-6574