Larynx Cancer Clinical Trial
Official title:
A Matched Case Clinical Registry - Efficacy of AmnioFix in the Prevention of Post-Operative Salivary Leaks Following Head and Neck Surgery
NCT number | NCT03479463 |
Other study ID # | AFSUR003 |
Secondary ID | |
Status | Terminated |
Phase | |
First received | |
Last updated | |
Start date | March 19, 2018 |
Est. completion date | March 30, 2019 |
Verified date | November 2020 |
Source | MiMedx Group, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
This trial aims to determine if intra-operative use of human dehydrated amnion chorion allograft improves post-operative patient healing outcomes.
Status | Terminated |
Enrollment | 8 |
Est. completion date | March 30, 2019 |
Est. primary completion date | March 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Subject is scheduled to undergo laryngectomy and/or pharyngectomy procedure due to oncological indication 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: 1. Subjects currently enrolled in or planning to enroll in another clinical trial 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) |
Country | Name | City | State |
---|---|---|---|
United States | Mount Sinai Hospital | New York | New York |
Lead Sponsor | Collaborator |
---|---|
MiMedx Group, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of Pharayngocutaneous Fistula Development (PCF) | Incidence of PCF developement necessitating intervention within the 60 day time point. | 60 days |
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