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

Laryngeal Cancer Clinical Trial

— TEP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03039465
• Other study ID #: HCG/SX/003/2016
• Status: Recruiting
• Phase: N/A
• First received: January 27, 2017
• Last updated: January 30, 2017
• Start date: April 18, 2016
• Est. completion date: December 31, 2017

Study information

• Verified date: January 2017
• Source: HealthCare Global Enterprise Ltd.
• Contact: Vishal US Rao, MS
• Phone: 9739774949
• Email: drvishalrao[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hypopharynx Cancer
• Laryngeal Cancer
• Laryngeal Neoplasms

Intervention

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)

Locations

Country	Name	City	State
India	HealthCare Global Enterprises Ltd	Bangalore	Karnataka

Sponsors (1)

Lead Sponsor	Collaborator
HealthCare Global Enterprise Ltd.

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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