Clinical Feasibility of New Tracheoesophageal Puncture Set

Study Overview
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Brief Summary
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During a total laryngectomy a puncture is created in the tracheoesophageal wall and a voice prosthesis is inserted. With this voice prosthesis the patient learns to speak again. During this study a new surgical tool will be investigated that creates the puncture and places the voice prosthesis.

Official Title
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Clinical Feasibility of a New Surgical Tool for Primary or Secondary Tracheoesophageal Puncture and Voice Prosthesis Insertion for Prosthetic Voice Rehabilitation After Total Laryngectomy

Conditions
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Larynx Cancer

Intervention / Treatment
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* Device: Puncture Set and Flexible Protector


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: primary puncture during total laryngectomy secondary puncture some time after total laryngectomy Exclusion Criteria: anatomical abnormalities that prevent appropriate pharynx protection during secondary puncture not eligible to use a voice prosthesis for other reasons

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Provox Vega Puncture Set
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Puncture Set and Flexible Protector<br>Provox Vega Puncture Set is used to create the primary puncture and insert the prosthesis during total laryngectomy | Device: Puncture Set and Flexible Protector<br>* The Provox Vega Puncture Set will be used to create the tracheoesophageal puncture and place the voice prosthesis. In secondary punctures the Provox Flexible Protector may be used for pharynx protection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success Rate of Procedure | As successful counted all successful procedures in which the tracheal flange of the voice prosthesis unfolded completely without help of additional tools. A success rate of 80% and higher was considered acceptable. | immediate observation during surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction of Physician | Satisfaction of the physicians with the new tools was investigated by asking them which tool set they prefer: the new set from the study or the set they would have normally used. | 1 month | 
| Cost Effectiveness Calculation | cost effectiveness of the new tool set is compared to that of the set that would have been used in the absence of the new puncture set. Measurements are: time needed to perform procedure | 1 month | 
| Postoperative Results | Patients were followed-up one month after surgery.Patients with secondary punctures filled out a questionnaire. | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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voice prosthesis, larynx cancer, laryngectomy