Larynx CancerNCT03479463
Use of Human Dehydrated Amnion Chorion Allograft in Laryngectomy/Pharyngectomy
An observational study of Larynx Cancer and Pharynx Cancer, run by MiMedx Group, Inc. at 1 site in United States.
Trial summary
This trial aims to determine if intra-operative use of human dehydrated amnion chorion allograft improves post-operative patient healing outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Larynx Cancer, Pharynx Cancer, Pharyngocutaneous Fistula
- What is being tested?
- Dehydrated human amnion/chorion membrane
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2018to 30 Mar 2019
- How long will I take part?
- 150 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Subject is scheduled to undergo laryngectomy and/or pharyngectomy procedure due to oncological indication
- Subject is age 18 or older
- Subject is willing and able to provide informed consent and participate in all procedures and follow-up evaluations necessary to complete the study
Who cannot join
- Subjects currently enrolled in or planning to enroll in another clinical trial
- Subjects with a known history of poor compliance with medical treatments
- Subjects that are using or have used an investigational drug, device, or biologic within the 12 weeks prior to treatment
- Subjects that have any significant medical condition(s) that, in the opinion of the Investigator, would interfere with protocol evaluation and participation
- Subject has undergone previous pharyngeal reconstructive surgery
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Matched Case Clinical Registry - Efficacy of AmnioFix in the Prevention of Post-Operative Salivary Leaks Following Head and Neck Surgery
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.
- Conditions
- Larynx Cancer, Pharynx Cancer, Pharyngocutaneous Fistula
- Being tested
- Dehydrated human amnion/chorion membrane
- Medical subject headings
- Laryngeal Neoplasms, Pharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dehydrated human amnion/chorion membraneBiological
Laryngectomy/pharyngectomy patched with dehydrated human amnion chorion allograft
| Study group | Role | What they receive |
|---|---|---|
| Treatment with Dehydrated Human Amnion Chorion Allograft | Not described Receives: Biological: Dehydrated human amnion/chorion membrane | |
| Standard of Care | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Pharayngocutaneous Fistula Development (PCF)
Incidence of PCF developement necessitating intervention within the 60 day time point.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start19 Mar 2018
- Primary completion30 Mar 2019
- Study completion30 Mar 2019
Why it stopped: Slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Larynx CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 8 participants (actual)
- Target duration
- 150 Days
Sponsor and investigators
- Lead sponsor
- MiMedx Group, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brett Miles, MD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03479463
- Sponsor's protocol ID
- AFSUR003
- Status last verified
- Nov 2020
- First submitted
- 20 Mar 2018
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Matched Case Clinical Registry - Efficacy of AmnioFix in the Prevention of Post-Operative Salivary Leaks Following Head and Neck Surgery
- ClinicalTrials.gov ID
- NCT03479463
- Acronym / sponsor ID
- AFSUR003
- Conditions
- Larynx Cancer, Pharynx Cancer, Pharyngocutaneous Fistula
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Slow enrollment
- Enrolment
- 8 participants (actual)
- Lead sponsor
- MiMedx Group, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Mar 2018 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 30 Mar 2019 (actual)
- First posted
- 27 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial aims to determine if intra-operative use of human dehydrated amnion chorion allograft improves post-operative patient healing outcomes.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 150 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment with Dehydrated Human Amnion Chorion Allograft | – | Biological: Dehydrated human amnion/chorion membrane |
| Standard of Care | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Subject is scheduled to undergo laryngectomy and/or pharyngectomy procedure due to oncological indication
- Subject is age 18 or older
- Subject is willing and able to provide informed consent and participate in all procedures and follow-up evaluations necessary to complete the study
Key exclusion criteria (6 listed)
- Subjects currently enrolled in or planning to enroll in another clinical trial
- Subjects with a known history of poor compliance with medical treatments
- Subjects that are using or have used an investigational drug, device, or biologic within the 12 weeks prior to treatment
- Subjects that have any significant medical condition(s) that, in the opinion of the Investigator, would interfere with protocol evaluation and participation
- Subject has undergone previous pharyngeal reconstructive surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dehydrated human amnion/chorion membraneLaryngectomy/pharyngectomy patched with dehydrated human amnion chorion allograft | Biological | Treatment with Dehydrated Human Amnion Chorion Allograft |
Primary outcome
Incidence of Pharayngocutaneous Fistula Development (PCF)
Time frame: 60 days
Incidence of PCF developement necessitating intervention within the 60 day time point.
Results and safety
The study was stopped early (reason given: Slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brett Miles, MD principal investigator
MOUNT SINAI HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Larynx Cancer and Pharynx Cancer, run by MiMedx Group, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slow enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Pharayngocutaneous Fistula Development (PCF) (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2020.