<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/NCT03039465</url>
  </required_header>
  <id_info>
    <org_study_id>HCG/SX/003/2016</org_study_id>
    <nct_id>NCT03039465</nct_id>
  </id_info>
  <brief_title>A Novel Modified Tracheo-Esophageal Voice Prosthesis for Total Laryngectomy Patients</brief_title>
  <acronym>TEP</acronym>
  <official_title>A Novel Modified Tracheo-Esophageal Voice Prosthesis for Total Laryngectomy Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>HealthCare Global Enterprise Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>HealthCare Global Enterprise Ltd.</source>
  <oversight_info>
    <has_dmc>No</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>
      This study is being conducted at Healthcare Global Enterprises Ltd to evaluate the role of a&#xD;
      novel Tracheo-Esophageal voice Prosthesis for total laryngectomy +/- partial pharyngectomy&#xD;
      patients. 30 patients will be enrolled as an inpatient or outpatient.&#xD;
&#xD;
      Patients who are planned to undergo total laryngectomy +/- pharyngectomy surgery and&#xD;
      trachea-esophageal puncture procedure.(for primary TEP insertion) or patients who have&#xD;
      undergone total laryngectomy &gt; 6weeks prior and are suitable candidates for secondary TEP&#xD;
      insertion would be recruited to the study. Insertion of the TEP will be done in primary&#xD;
      setting or secondary setting. Patients, who are undergoing primary TEP insertion, will be&#xD;
      evaluated for speech/ voice at an interval of 6 weeks, 12 weeks and 6 months after the&#xD;
      procedure. Patients who are undergoing secondary TEP insertion to be evaluated on the same&#xD;
      day of the procedure along with evaluation at an interval of 6 weeks, 12 weeks and 6 months.&#xD;
      All the patients will be evaluated clinically for a fluid leak (through and around the TEP)&#xD;
      on the same days of voice analysis by giving test feeds under supervision.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is being conducted at Healthcare Global Enterprises Ltd to evaluate the role of a&#xD;
      novel trachea-oesophageal prosthesis for total laryngectomy +/- partial pharyngectomy&#xD;
      patients. 30 patients will be enrolled as an inpatient or outpatient.&#xD;
&#xD;
      Patients who are planned to undergo total laryngectomy +/- pharyngectomy surgery and&#xD;
      trachea-esophageal puncture procedure.(for primary TEP insertion) or patients who have&#xD;
      undergone total laryngectomy &gt; 6weeks prior and are suitable candidates for secondary TEP&#xD;
      insertion would be recruited to the study. Insertion of the TEP will be done in primary&#xD;
      setting or secondary setting. Patients, who are undergoing primary TEP insertion, will be&#xD;
      evaluated for speech/ voice at an interval of 6 weeks, 12 weeks and 6 months after the&#xD;
      procedure. Patients who are undergoing secondary TEP insertion to be evaluated on the same&#xD;
      day of the procedure along with evaluation at an interval of 6 weeks, 12 weeks and 6 months.&#xD;
      All the patients will be evaluated clinically for fluid leak (through and around the TEP) on&#xD;
      the same days of voice analysis by giving test feeds under supervision.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 18, 2016</start_date>
  <completion_date type="Anticipated">December 31, 2017</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2017</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>
    <intervention_model_description>A single group of patients undergoing the insertion of the prosthesis would be evaluated for voice quality and fluid leak as a measure of success of the intervention.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Voice Quality</measure>
    <time_frame>Assessments would be done 6 weeks, 12 weeks and 6 months post surgery</time_frame>
    <description>Voice quality would be assessed by a speech therapist using a standardized questionnaire to assess the functionality of the modified TEP</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Presence / Absence of Fluid Leak</measure>
    <time_frame>Immediately, 6 weeks, 12 weeks and 6 months after the Modified TEP insertion procedure</time_frame>
    <description>Clinical assessment of modified TEP leak after a test fluid feed</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Laryngeal Cancer</condition>
  <condition>Hypopharynx Cancer</condition>
  <arm_group>
    <arm_group_label>Modified Trans-Esophageal Prosthesis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients satisfying the selection criteria would be subjected to the insertion of the TEP and evaluated at subsequent time points for the success of the procedure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Modified Trans-Esophageal Prosthesis</intervention_name>
    <description>This device is a biomedical grade silicon voice prosthesis with an inner esophageal flange, a stem and an outer tracheal flange. Insertion would be done through a modified 'romovac' inserter set / curved metal inserter (provided with the TEP) and an oesophagoscope in case of secondary insertion would be used. in patients with existing TEP puncture / who require a TEP change, on out-patient basis, the insertion would be done with a novel two-part inserter device (front loading)</description>
    <arm_group_label>Modified Trans-Esophageal Prosthesis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who are surgically and medically fit for undergoing a total laryngectomy +/-&#xD;
             partial pharyngectomy.&#xD;
&#xD;
          -  Patients who have already undergone total laryngectomy +/- partial pharyngectomy and&#xD;
             are willing for a secondary voice rehabilitation procedure.&#xD;
&#xD;
          -  Patient signing the informed consent for procedure after understanding the details&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Partial laryngectomy&#xD;
&#xD;
          -  Near total laryngectomy&#xD;
&#xD;
          -  Patient unfit for the procedure&#xD;
&#xD;
          -  Patients not consenting for the procedure&#xD;
&#xD;
          -  Patients utilizing alternative ways of post laryngectomy voice rehabilitation (for&#xD;
             secondary insertion)&#xD;
&#xD;
          -  Patients with stricture in pharynx (for secondary insertion)&#xD;
&#xD;
          -  Partial pharyngectomy reconstruction, not permitting insertion of TEP&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vishal US Rao, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dept of Head &amp; Neck Surgery, HealthCare Global Enterprises Ltd.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Vishal US Rao, MS</last_name>
    <phone>9739774949</phone>
    <email>drvishalrao@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Satakshi Chatterjee, MS</last_name>
    <phone>8971966903</phone>
    <email>sataksis2007@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>HealthCare Global Enterprises Ltd</name>
      <address>
        <city>Bangalore</city>
        <state>Karnataka</state>
        <zip>560027</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vishal US Rao, MS</last_name>
      <phone>00919739774949</phone>
      <email>drvishalrao@yahoo.com</email>
    </contact>
    <contact_backup>
      <last_name>Sataksi Chatterjee, MS</last_name>
      <phone>00918971966903</phone>
      <email>sataksis2007@gmail.com</email>
    </contact_backup>
    <investigator>
      <last_name>Sataksi Chaterjee, MS</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 27, 2017</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <last_update_submitted>January 30, 2017</last_update_submitted>
  <last_update_submitted_qc>January 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>HealthCare Global Enterprise Ltd.</investigator_affiliation>
    <investigator_full_name>Vishal U S Rao</investigator_full_name>
    <investigator_title>Head, Dept of Head &amp; Neck Surgery</investigator_title>
  </responsible_party>
  <keyword>Indwelling Trachea-oesophageal Prosthesis</keyword>
  <keyword>Voice Rehabilitation</keyword>
  <keyword>Total Laryngectomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Laryngeal Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Overall results of the study would be made public but individual patient data would be not be made available</ipd_description>
  </patient_data>
  <pending_results>
    <submitted>June 17, 2019</submitted>
    <returned>August 2, 2019</returned>
    <submitted>January 23, 2020</submitted>
    <returned>February 5, 2020</returned>
  </pending_results>
  <!-- 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/NCT03039465
org study id: HCG/SX/003/2016
nct id: NCT03039465
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is being conducted at Healthcare Global Enterprises Ltd to evaluate the role of a
      novel Tracheo-Esophageal voice Prosthesis for total laryngectomy +/- partial pharyngectomy
      patients. 30 patients will be enrolled as an inpatient or outpatient.

      Patients who are planned to undergo total laryngectomy +/- pharyngectomy surgery and
      trachea-esophageal puncture procedure.(for primary TEP insertion) or patients who have
      undergone total laryngectomy > 6weeks prior and are suitable candidates for secondary TEP
      insertion would be recruited to the study. Insertion of the TEP will be done in primary
      setting or secondary setting. Patients, who are undergoing primary TEP insertion, will be
      evaluated for speech/ voice at an interval of 6 weeks, 12 weeks and 6 months after the
      procedure. Patients who are undergoing secondary TEP insertion to be evaluated on the same
      day of the procedure along with evaluation at an interval of 6 weeks, 12 weeks and 6 months.
      All the patients will be evaluated clinically for a fluid leak (through and around the TEP)
      on the same days of voice analysis by giving test feeds under supervision.
This study is being conducted at Healthcare Global Enterprises Ltd to evaluate the role of a
      novel trachea-oesophageal prosthesis for total laryngectomy +/- partial pharyngectomy
      patients. 30 patients will be enrolled as an inpatient or outpatient.

      Patients who are planned to undergo total laryngectomy +/- pharyngectomy surgery and
      trachea-esophageal puncture procedure.(for primary TEP insertion) or patients who have
      undergone total laryngectomy > 6weeks prior and are suitable candidates for secondary TEP
      insertion would be recruited to the study. Insertion of the TEP will be done in primary
      setting or secondary setting. Patients, who are undergoing primary TEP insertion, will be
      evaluated for speech/ voice at an interval of 6 weeks, 12 weeks and 6 months after the
      procedure. Patients who are undergoing secondary TEP insertion to be evaluated on the same
      day of the procedure along with evaluation at an interval of 6 weeks, 12 weeks and 6 months.
      All the patients will be evaluated clinically for fluid leak (through and around the TEP) on
      the same days of voice analysis by giving test feeds under supervision.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: A single group of patients undergoing the insertion of the prosthesis would be evaluated for voice quality and fluid leak as a measure of success of the intervention.
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in Voice Quality
time frame: Assessments would be done 6 weeks, 12 weeks and 6 months post surgery
description: Voice quality would be assessed by a speech therapist using a standardized questionnaire to assess the functionality of the modified TEP
measure: Change in Presence / Absence of Fluid Leak
time frame: Immediately, 6 weeks, 12 weeks and 6 months after the Modified TEP insertion procedure
description: Clinical assessment of modified TEP leak after a test fluid feed
arm group label: Modified Trans-Esophageal Prosthesis
arm group type: Experimental
description: Patients satisfying the selection criteria would be subjected to the insertion of the TEP and evaluated at subsequent time points for the success of the procedure.
intervention type: Device
intervention name: Modified Trans-Esophageal Prosthesis
description: This device is a biomedical grade silicon voice prosthesis with an inner esophageal flange, a stem and an outer tracheal flange. Insertion would be done through a modified 'romovac' inserter set / curved metal inserter (provided with the TEP) and an oesophagoscope in case of secondary insertion would be used. in patients with existing TEP puncture / who require a TEP change, on out-patient basis, the insertion would be done with a novel two-part inserter device (front loading)
arm group label: Modified Trans-Esophageal Prosthesis
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Vishal US Rao, MS
role: Principal Investigator
affiliation: Dept of Head & Neck Surgery, HealthCare Global Enterprises Ltd.
last name: Vishal US Rao, MS
phone: 9739774949
email: drvishalrao@yahoo.com
last name: Satakshi Chatterjee, MS
phone: 8971966903
email: sataksis2007@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: India
responsible party type: Principal Investigator
investigator affiliation: HealthCare Global Enterprise Ltd.
investigator full name: Vishal U S Rao
investigator title: Head, Dept of Head & Neck Surgery
mesh term: Laryngeal Neoplasms
sharing ipd: No
ipd description: Overall results of the study would be made public but individual patient data would be not be made available
submitted: June 17, 2019
returned: August 2, 2019
submitted: January 23, 2020
returned: February 5, 2020