Clinical Feasibility of New Tracheoesophageal Puncture Set

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Atos Medical AB
ClinicalTrials.gov Identifier:
NCT01045057
First received: January 6, 2010
Last updated: February 10, 2015
Last verified: February 2015
  Purpose

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 Intervention Phase
Larynx Cancer
Device: Puncture Set and Flexible Protector
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by Atos Medical AB:

Primary Outcome Measures:
  • Success Rate of Procedure [ Time Frame: immediate observation during surgery ] [ Designated as safety issue: No ]
    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:
  • Satisfaction of Physician [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    Patients were followed-up one month after surgery.Patients with secondary punctures filled out a questionnaire.


Enrollment: 27
Study Start Date: December 2009
Study Completion Date: April 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01045057

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

No publications provided

Responsible Party: Atos Medical AB
ClinicalTrials.gov Identifier: NCT01045057     History of Changes
Other Study ID Numbers: UD743_FRITZ_MULTI
Study First Received: January 6, 2010
Results First Received: January 15, 2015
Last Updated: February 10, 2015
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

ClinicalTrials.gov processed this record on April 26, 2015