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

Not Applicable

• Conditions: Hypopharynx Cancer; Laryngeal Cancer
• Interventions: Device: Modified Trans-Esophageal Prosthesis

• Registration Number: NCT03039465
• Lead Sponsor: HealthCare Global Enterprise Ltd.

Brief Summary

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

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 Timeline

• Study Start: 2016-04-18
• Status Verified: 2017-01
• Study First Submitted: 2017-01-27
• Study First Submitted QC: 2017-01-30
• Last Update Submitted: 2017-01-30
• Study First Posted: 2017-02-01
• Last Update Posted: 2017-02-01
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Modified Trans-Esophageal Prosthesis	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.

Primary Outcome Measures

Name	Time	Method
Change in Voice Quality	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
Change in Presence / Absence of Fluid Leak	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

Trial Locations

Locations (1)

HealthCare Global Enterprises Ltd; 🇮🇳 Bangalore, Karnataka, India