Clinical Feasibility of New Tracheoesophageal Puncture Set

Larynx Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01045057
• Other study ID #: UD743_FRITZ_MULTI
• Status: Completed
• Phase: N/A
• Start date: December 2009
• Est. completion date: April 2011

Study information

• Verified date: June 2021
• Source: Atos Medical AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: April 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Laryngeal Neoplasms
• Larynx Cancer

Intervention

Device:
• Puncture Set and Flexible Protector
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.

Locations

Country	Name	City	State
Belgium	University Hospital Leuven	Leuven
Germany	Bundeswehr Krankenhaus	Ulm
Netherlands	Netherlands Cancer Institute	Amsterdam	Noord Holland
Netherlands	Erasmus Medical Center	Rotterdam	Zuid-Holland
Spain	Hospital de la Santa Creu I Sant Pau Universitat Autònoma de Barcelona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Atos Medical AB

Countries where clinical trial is conducted

Belgium,  Germany,  Netherlands,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Postoperative Results	Patients were followed-up one month after surgery.Patients with secondary punctures filled out a questionnaire.	1 month