Clinical Trial: Clinical Feasibility of New Tracheoesophageal Puncture Set

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: Atos Medical AB

Current Primary Outcome: 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.


Original Primary Outcome:

Current Secondary Outcome:

  • Satisfaction of Physician [ Time Frame: 1 month ]
    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.
  • Cost Effectiveness Calculation [ Time Frame: 1 month ]

    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

  • Postoperative Results [ Time Frame: 1 month ]
    Patients were followed-up one month after surgery.Patients with secondary punctures filled out a questionnaire.


Original Secondary Outcome:

Information By: Atos Medical AB

Dates:
Date Received: January 6, 2010
Date Started: December 2009
Date Completion:
Last Updated: February 10, 2015
Last Verified: February 2015