Use of Human Dehydrated Amnion Chorion Allograft in Laryngectomy/Pharyngectomy

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)