A Novel Modified Tracheo-Esophageal Voice Prosthesis for Total Laryngectomy Patients (TEP)

January 30, 2017 updated by: Vishal U S Rao, HealthCare Global Enterprise Ltd.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Karnataka
      • Bangalore, Karnataka, India, 560027
        • Recruiting
        • Healthcare Global Enterprises Ltd
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Sataksi Chaterjee, MS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who are surgically and medically fit for undergoing a total laryngectomy +/- partial pharyngectomy.
  • Patients who have already undergone total laryngectomy +/- partial pharyngectomy and are willing for a secondary voice rehabilitation procedure.
  • Patient signing the informed consent for procedure after understanding the details

Exclusion Criteria:

  • Partial laryngectomy
  • Near total laryngectomy
  • Patient unfit for the procedure
  • Patients not consenting for the procedure
  • Patients utilizing alternative ways of post laryngectomy voice rehabilitation (for secondary insertion)
  • Patients with stricture in pharynx (for secondary insertion)
  • Partial pharyngectomy reconstruction, not permitting insertion of TEP

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Modified Trans-Esophageal Prosthesis
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.
Device: Modified Trans-Esophageal Prosthesis
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Voice Quality
Time Frame: Assessments would be done 6 weeks, 12 weeks and 6 months post surgery
Voice quality would be assessed by a speech therapist using a standardized questionnaire to assess the functionality of the modified TEP
Assessments would be done 6 weeks, 12 weeks and 6 months post surgery
Change in Presence / Absence of Fluid Leak
Time Frame: Immediately, 6 weeks, 12 weeks and 6 months after the Modified TEP insertion procedure
Clinical assessment of modified TEP leak after a test fluid feed
Immediately, 6 weeks, 12 weeks and 6 months after the Modified TEP insertion procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HealthCare Global Enterprise Ltd.

Investigators

  • Principal Investigator: Vishal US Rao, MS, Dept of Head & Neck Surgery, HealthCare Global Enterprises Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 18, 2016

Primary Completion (ANTICIPATED)

December 31, 2017

Study Completion (ANTICIPATED)

December 31, 2017

Study Registration Dates

First Submitted

January 27, 2017

First Submitted That Met QC Criteria

January 30, 2017

First Posted (ESTIMATE)

February 1, 2017

Study Record Updates

Last Update Posted (ESTIMATE)

February 1, 2017

Last Update Submitted That Met QC Criteria

January 30, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCG/SX/003/2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Overall results of the study would be made public but individual patient data would be not be made available

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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