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

NCT03039465 | Unknown

• 1 other identifier: HCG/SX/003/2016
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Laryngeal Cancer; Hypopharynx Cancer

Keywords

Indwelling Trachea-oesophageal Prosthesis; Voice Rehabilitation; Total Laryngectomy

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Modified Trans-Esophageal Prosthesis

EXPERIMENTAL

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

Interventions

Modified Trans-Esophageal Prosthesis DEVICE

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)

Modified Trans-Esophageal Prosthesis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• HealthCare Global Enterprise Ltd.: lead

Study Sites (1)

HealthCare Global Enterprises Ltd

Bangalore, Karnataka, 560027, India

RECRUITING

MeSH Terms

Conditions

Laryngeal Neoplasms; Hypopharyngeal Neoplasms

Condition Hierarchy (Ancestors)

Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Otorhinolaryngologic Diseases; Pharyngeal Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases

Study Officials

• Vishal US Rao, MS

  Dept of Head & Neck Surgery, HealthCare Global Enterprises Ltd.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vishal US Rao, MS

CONTACT

9739774949; drvishalrao@yahoo.com

Satakshi Chatterjee, MS

CONTACT

8971966903; sataksis2007@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Dept of Head & Neck Surgery

Model Details: 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.

Study Record Dates

• First Submitted: January 27, 2017
• First Posted: February 1, 2017
• Study Start: April 18, 2016
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: February 1, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)