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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:

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.


Sponsor: HealthCare Global Enterprise Ltd.

Current Primary Outcome:

  • 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
  • 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: HealthCare Global Enterprise Ltd.

Dates:
Date Received: January 27, 2017
Date Started: April 18, 2016
Date Completion: December 31, 2017
Last Updated: January 30, 2017
Last Verified: January 2017