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

HealthCare Global

Status: Unknown

Conditions: Laryngeal Cancer; Hypopharynx Cancer

Treatments: Device: Modified Trans-Esophageal Prosthesis

Study type: Interventional

Funder types: Industry

Identifiers

NCT03039465

HCG/SX/003/2016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Modified Trans-Esophageal Prosthesis

Experimental group

Description:

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.

Treatment:

Device: Modified Trans-Esophageal Prosthesis