ClinicalTrials.gg
TerminatedNCT03479463Updated Nov 13, 2020

Use of Human Dehydrated Amnion Chorion Allograft in Laryngectomy/Pharyngectomy

An observational study in Larynx Cancer, Pharynx Cancer and Pharyngocutaneous Fistula, sponsored by MiMedx Group, Inc.. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-13.

Sponsored by MiMedx Group, Inc. · Observational

Why this study was terminated
Slow enrollment
Study type
Observational
Model
Case-control
Time perspective
Other
Enrollment
8
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 131 studies in Laryngeal Neoplasms with a site in United States — 33 open to participants now, 46 under way, 3 of them phase 3. Laryngeal Neoplasms · United States.

Enrollment
19th of 20
8 · median 252
Started
2018
with 6 others
Observational
20 of 131
5 open now
Registered
81st of 131
by date

Among the 131 studies in Laryngeal Neoplasms with a site in United States, this one is the 19th largest by enrollment of the 20 observational ones that give a count, is one of 7 that started in 2018, is one of 20 observational ones, and was the 81st registered.

Laryngeal Neoplasms

257 studies on the registry are indexed under Laryngeal Neoplasms; 68 are open to participants now.

Browse Laryngeal Neoplasms studies →

Open to participants now

33 of the 131 studies in Laryngeal Neoplasms with a site in United States are open now. Recruiting first, the newest first:

28 more — sign in →

All 33 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 56 Laryngeal Neoplasms studies recruiting now, 41 (73%) set no upper age limit and 6 (11%) stop at 75 or younger; 3 take children under 18; 3 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study summary

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

Read the 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.

03

Conditions studied

  • Larynx Cancer
  • Pharynx Cancer
  • Pharyngocutaneous Fistula
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

This is a single-center, matched case registry. The medical records of approximately 40 patients meeting all documentation and eligibility requirements will comprise the retrospective cohort. A total of 40 subjects will be enrolled prospectively at Mount Sinai Hospital. It is expected that the majority of the subjects will be recruited through the investigators' standard admission practices. All subjects selected for the study will not be excluded because of race or ethnicity and all efforts will be made to adequately represent the patient population in the area in which they are chosen.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 and participate in all procedures and follow-up evaluations necessary to complete the study

Exclusion criteria

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 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 who are planning to become pregnant during the time of the study OR are unwilling/unable to use acceptable methods of (birth control pills, barriers, or abstinence)
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Observational model
Case-control
Time perspective
Other
Enrollment
8 participants (actual)
Target follow-up
150 Days
Patient registry
Yes

Groups and cohorts

  • Treatment with Dehydrated Human Amnion Chorion Allograft

    Biological: Dehydrated human amnion/chorion membrane

  • Standard of Care

Interventions

06

What researchers measure

Primary outcomes

  1. Incidence of Pharayngocutaneous Fistula Development (PCF)

    Incidence of PCF developement necessitating intervention within the 60 day time point.

    Time frame: 60 days

07

Study locations

1 site
  • Mount Sinai Hospital
    New York, New York 10029-6574, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2018 to primary completion in Mar 2019, 12 months.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 20, 2018
First posted
Mar 27, 2018
StartActual
Mar 19, 2018
Primary completionActual
Mar 30, 2019
CompletionActual
Mar 30, 2019
Last update
Nov 13, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 13, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03479463
Lead sponsor
MiMedx Group, Inc.
Responsible party
Sponsor
First posted
Mar 27, 2018
Start date
Mar 19, 2018
Primary completion
Mar 30, 2019
Completion
Mar 30, 2019
Last update
Nov 13, 2020

Study contacts

Brett Miles, MD
principal investigator · MOUNT SINAI HOSPITAL

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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