<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03269396</url>
  </required_header>
  <id_info>
    <org_study_id>15-005642</org_study_id>
    <nct_id>NCT03269396</nct_id>
  </id_info>
  <brief_title>Laryngeal Allograft Transplantation</brief_title>
  <official_title>A Prospective Nonrandomized Study of Laryngeal Allograft Transplantation Clinical Investigation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this proposed study is to obtain safety and efficacy data on human laryngeal&#xD;
      allograft transplantation in an effort to safely use these procedures as a viable&#xD;
      reconstructive option for patients with severe laryngeal or laryngotracheal incompetence.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with severe laryngeal or laryngotracheal incompetence without other reconstructive&#xD;
      options will be considered for cadaveric laryngotracheal transplantation. Data will be&#xD;
      collected from 10 patients and will include length of hospital stay, short-term&#xD;
      complications, long-term complications, hospital readmission, return trips to the operating&#xD;
      room (OR), rejection episodes and severity, swallowing function, ability to have tracheotomy&#xD;
      tube decannulated, voice parameters, pulmonary function, development of anti-donor&#xD;
      antibodies, and quality of life scores.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">May 1, 2022</start_date>
  <completion_date type="Anticipated">May 2028</completion_date>
  <primary_completion_date type="Anticipated">May 2028</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Survival of the allograft at the one-year visit.</measure>
    <time_frame>1 year</time_frame>
    <description>Survival of the allograft as indicated by histological rejection grading.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Swallowing without aspiration at the one-year visit.</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Voice Evaluation</measure>
    <time_frame>1 year</time_frame>
    <description>Standard voice evaluation will include voice recordings, acoustic and aerodynamic measurements as compared to baseline measurements.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulmonary function</measure>
    <time_frame>1 year</time_frame>
    <description>Pulmonary function values within normal range.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ability to have tracheotomy tube decannulated</measure>
    <time_frame>1 year</time_frame>
    <description>Ability to have tracheotomy tube decannulated after successful capping trials.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Larynx Stenosis</condition>
  <condition>Larynx Disease</condition>
  <condition>Laryngectomy</condition>
  <condition>Larynx</condition>
  <condition>Larynx Fracture</condition>
  <arm_group>
    <arm_group_label>Larynx Allograft Transplantation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cadaveric laryngotracheal transplantation</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Larynx Allograft Transplantation</intervention_name>
    <description>This study is a prospective clinical trial designed to assess the efficacy and safety of laryngeal transplantation. A total of 10 patients will be enrolled over a five-year timeframe. Study length is 5 years.</description>
    <arm_group_label>Larynx Allograft Transplantation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Potential subjects for this study include patients with severe laryngeal dysfunction or a&#xD;
        previous laryngectomy. For the purposes of this study, severe laryngeal dysfunction is&#xD;
        defined as the loss of normal laryngeal function resulting in significant dysphonia,&#xD;
        dysphagia, or dyspnea.&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Ages 18 years and older&#xD;
&#xD;
          -  Male or Female&#xD;
&#xD;
          -  One of the following:&#xD;
&#xD;
               -  Severe laryngeal dysfunction as described above&#xD;
&#xD;
               -  Laryngeal stenosis&#xD;
&#xD;
               -  5 years or longer s/p definitive management for head and neck cancer&#xD;
&#xD;
               -  Laryngeal cancer requiring total laryngectomy in a patient already on&#xD;
                  immunosuppression&#xD;
&#xD;
               -  Low-grade chondrosarcoma requiring total laryngectomy&#xD;
&#xD;
          -  Ability to obtain informed consent from the patient&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Poor surgical candidacy secondary to poor physical/mental health as determined by a&#xD;
        pre-operative medical evaluation&#xD;
&#xD;
        General medical status&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Any systemic disease which would alter life expectancy&#xD;
&#xD;
               -  Active neoplastic disease, not considered yet to be cured (Exceptional cases will&#xD;
                  be considered in case by case discussion)Less than 5 years s/p definitive&#xD;
                  management for cancer&#xD;
&#xD;
               -  Cancer within the last 5 years (Exceptional cases will be considered in case by&#xD;
                  case discussion)&#xD;
&#xD;
               -  Obesity (Body Mass Index &gt;29 - 30)(Exceptional cases will be considered on a case&#xD;
                  by case basis)&#xD;
&#xD;
               -  Cachexia (BMI&lt;18)(Exceptional cases will be considered on a case by case basis)&#xD;
                  Significant renal dysfunction (Creatinine clearance &lt; 50 ml/min.)&#xD;
&#xD;
               -  Significant hepatic dysfunction&#xD;
&#xD;
               -  Significant kidney damage&#xD;
&#xD;
               -  Unmanageable infections&#xD;
&#xD;
               -  Unable to participate in preoperative exercise training&#xD;
&#xD;
               -  Unable to be weaned to equal or less than 10 mg/day of steroids&#xD;
&#xD;
               -  Untreatable cardiac disease&#xD;
&#xD;
               -  Active neuromuscular disease&#xD;
&#xD;
               -  History of recurrent aspiration or active, unmanageable Gastro-Esophageal Reflux&#xD;
&#xD;
               -  Patients with active connective tissue diseases (exceptions to be considered in a&#xD;
                  case by case basis)&#xD;
&#xD;
               -  Patients unable to achieve &gt; 600 feet in a 6 minute walk test (exceptions to be&#xD;
                  considered in a case by case basis)&#xD;
&#xD;
               -  Patients considered having active immunodeficiency disorders (exceptions to be&#xD;
                  considered in a case by case basis)&#xD;
&#xD;
               -  Multiple co-morbidities that would make transplantation prohibitively risky&#xD;
&#xD;
          -  Psychosocial parameters&#xD;
&#xD;
               -  Severe mental retardation, psychosis, depression or organic brain syndrome&#xD;
&#xD;
               -  Uncontrolled diabetes mellitus. Once HbA1C &lt; 7, reevaluate for candidacy.&#xD;
&#xD;
               -  Active substance use within 6 months&#xD;
&#xD;
               -  Active smoking within 6 months&#xD;
&#xD;
               -  Active alcoholism within 6 months&#xD;
&#xD;
               -  Inability to comply with transplant-related management and medical follow-up&#xD;
&#xD;
               -  Any other circumstances that deem the candidate high risk from a psychosocial&#xD;
                  perspective&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David G Lott</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Arizona</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85259</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>July 3, 2023</last_update_submitted>
  <last_update_submitted_qc>July 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>David G. Lott, M.D.</investigator_full_name>
    <investigator_title>Consultant-Department of Otolaryngology Head &amp; Neck Surgery/Audiology</investigator_title>
  </responsible_party>
  <keyword>severe laryngotracheal dysfunction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Laryngeal Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03269396
org study id: 15-005642
nct id: NCT03269396
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this proposed study is to obtain safety and efficacy data on human laryngeal
      allograft transplantation in an effort to safely use these procedures as a viable
      reconstructive option for patients with severe laryngeal or laryngotracheal incompetence.
Patients with severe laryngeal or laryngotracheal incompetence without other reconstructive
      options will be considered for cadaveric laryngotracheal transplantation. Data will be
      collected from 10 patients and will include length of hospital stay, short-term
      complications, long-term complications, hospital readmission, return trips to the operating
      room (OR), rejection episodes and severity, swallowing function, ability to have tracheotomy
      tube decannulated, voice parameters, pulmonary function, development of anti-donor
      antibodies, and quality of life scores.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Survival of the allograft at the one-year visit.
time frame: 1 year
description: Survival of the allograft as indicated by histological rejection grading.
measure: Swallowing without aspiration at the one-year visit.
time frame: 1 year
measure: Voice Evaluation
time frame: 1 year
description: Standard voice evaluation will include voice recordings, acoustic and aerodynamic measurements as compared to baseline measurements.
measure: Pulmonary function
time frame: 1 year
description: Pulmonary function values within normal range.
measure: Ability to have tracheotomy tube decannulated
time frame: 1 year
description: Ability to have tracheotomy tube decannulated after successful capping trials.
arm group label: Larynx Allograft Transplantation
arm group type: Experimental
description: Cadaveric laryngotracheal transplantation
intervention type: Procedure
intervention name: Larynx Allograft Transplantation
description: This study is a prospective clinical trial designed to assess the efficacy and safety of laryngeal transplantation. A total of 10 patients will be enrolled over a five-year timeframe. Study length is 5 years.
arm group label: Larynx Allograft Transplantation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: David G Lott
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: David G. Lott, M.D.
investigator title: Consultant-Department of Otolaryngology Head & Neck Surgery/Audiology
mesh term: Laryngeal Diseases
sharing ipd: No