Clinical Feasibility of New Tracheoesophageal Puncture Set

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01045057
Recruitment Status : Completed
First Posted : January 8, 2010
Results First Posted : February 10, 2015
Last Update Posted : February 27, 2015
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Larynx Cancer Device: Puncture Set and Flexible Protector Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : December 2009
Actual Primary Completion Date : March 2011
Actual Study Completion Date : April 2011

Arm Intervention/treatment
Experimental: Puncture Set and Flexible Protector
Provox Vega Puncture Set is used to create the primary puncture and insert the prosthesis during total laryngectomy
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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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

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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01045057

University Hospital Leuven
Leuven, Belgium, 3000
Bundeswehr Krankenhaus
Ulm, Germany, 89081
Netherlands Cancer Institute
Amsterdam, Noord Holland, Netherlands, 1066 CX
Erasmus Medical Center
Rotterdam, Zuid-Holland, Netherlands, 3015GD
Hospital de la Santa Creu I Sant Pau Universitat Autònoma de Barcelona
Barcelona, Spain, 08025
Sponsors and Collaborators
Atos Medical AB
Principal Investigator: Frans JM Hilgers, MD, PhD The Netherlands Cancer Institute

Responsible Party: Atos Medical AB Identifier: NCT01045057     History of Changes
Other Study ID Numbers: UD743_FRITZ_MULTI
First Posted: January 8, 2010    Key Record Dates
Results First Posted: February 10, 2015
Last Update Posted: February 27, 2015
Last Verified: February 2015

Keywords provided by Atos Medical AB:
voice prosthesis, larynx cancer, laryngectomy

Additional relevant MeSH terms:
Laryngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Laryngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Otorhinolaryngologic Diseases