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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Novel Modified Tracheo-Esophageal Voice Prosthesis for Total Laryngectomy Patients

Conditions
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Laryngeal Cancer, Hypopharynx Cancer

Intervention / Treatment
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* Device: Modified Trans-Esophageal Prosthesis


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Modified Trans-Esophageal Prosthesis<br>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<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Voice Quality | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Indwelling Trachea-oesophageal Prosthesis, Voice Rehabilitation, Total Laryngectomy