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Clinical Trial Details — Status: Terminated

Administrative data

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

Study information

Verified date November 2020
Source MiMedx Group, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

This trial aims to determine if intra-operative use of human dehydrated amnion chorion allograft improves post-operative patient healing outcomes.


Description:

This study is to determine if intra-operative use of Amnio-Fix improves post-operative patient healing outcomes after laryngectomy and/or pharyngectomy.


Recruitment information / eligibility

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)

Study Design


Intervention

Biological:
Dehydrated human amnion/chorion membrane
Laryngectomy/pharyngectomy patched with dehydrated human amnion chorion allograft

Locations

Country Name City State
United States Mount Sinai Hospital New York New York

Sponsors (1)

Lead Sponsor Collaborator
MiMedx Group, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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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