Clinical Feasibility of New Tracheoesophageal Puncture Set

Not Applicable

Completed

• Conditions: Larynx Cancer
• Interventions: Device: Puncture Set and Flexible Protector

• Registration Number: NCT01045057
• Lead Sponsor: Atos Medical AB

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 Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2010-01-06
• Study First Submitted QC: 2010-01-07
• Study First Posted: 2010-01-08
• Primary Completion: 2011-03
• Study Completion: 2011-04
• Results First Submitted: 2015-01-15
• Results First Submitted QC: 2015-01-15
• Results First Posted: 2015-02-10
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-03
• Last Update Posted: 2021-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Puncture Set and Flexible Protector	Puncture Set and Flexible Protector	Provox Vega Puncture Set is used to create the primary puncture and insert the prosthesis during total laryngectomy

Primary Outcome Measures

Name	Time	Method
Success Rate of Procedure	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.

Secondary Outcome Measures

Name	Time	Method
Satisfaction of Physician	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.
Postoperative Results	1 month	Patients were followed-up one month after surgery.Patients with secondary punctures filled out a questionnaire.
Cost Effectiveness Calculation	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

Trial Locations

Locations (5)

Hospital de la Santa Creu I Sant Pau Universitat Autònoma de Barcelona; 🇪🇸 Barcelona, Spain

Erasmus Medical Center; 🇳🇱 Rotterdam, Zuid-Holland, Netherlands

Netherlands Cancer Institute; 🇳🇱 Amsterdam, Noord Holland, Netherlands

Bundeswehr Krankenhaus; 🇩🇪 Ulm, Germany

University Hospital Leuven; 🇧🇪 Leuven, Belgium