Use of Human Dehydrated Amnion Chorion Allograft in Laryngectomy/Pharyngectomy
NCT ID: NCT03479463
Last Updated: 2020-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
8 participants
OBSERVATIONAL
2018-03-19
2019-03-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
OTHER
Study Groups
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Treatment with Dehydrated Human Amnion Chorion Allograft
Dehydrated human amnion/chorion membrane
Laryngectomy/pharyngectomy patched with dehydrated human amnion chorion allograft
Standard of Care
No interventions assigned to this group
Interventions
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Dehydrated human amnion/chorion membrane
Laryngectomy/pharyngectomy patched with dehydrated human amnion chorion allograft
Eligibility Criteria
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Inclusion Criteria
2. Subject is age 18 or older
3. Subject is willing and able to provide informed consent and participate in all procedures and follow-up evaluations necessary to complete the study
Exclusion Criteria
2. Subjects with a known history of poor compliance with medical treatments
3. Subjects that are using or have used an investigational drug, device, or biologic within the 12 weeks prior to treatment
4. Subjects that have any significant medical condition(s) that, in the opinion of the Investigator, would interfere with protocol evaluation and participation
5. Subject has undergone previous pharyngeal reconstructive surgery
6. 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)
18 Years
ALL
No
Sponsors
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MiMedx Group, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Brett Miles, MD
Role: PRINCIPAL_INVESTIGATOR
MOUNT SINAI HOSPITAL
Locations
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Mount Sinai Hospital
New York, New York, United States
Countries
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Other Identifiers
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AFSUR003
Identifier Type: -
Identifier Source: org_study_id