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 ]
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