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

Atos Medical AB5 sites in 4 countries27 target enrollmentDecember 2009

ConditionsLarynx Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Larynx Cancer
Sponsor: Atos Medical AB
Enrollment: 27
Locations: 5
Primary Endpoint: Success Rate of Procedure
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

December 2009

End Date

April 2011

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Atos Medical AB

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Success Rate of Procedure

Time Frame: immediate observation during surgery

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.