Clinical Feasibility of New Tracheoesophageal Puncture Set

June 3, 2021 updated by: Atos Medical AB

Clinical Feasibility of a New Surgical Tool for Primary or Secondary Tracheoesophageal Puncture and Voice Prosthesis Insertion for Prosthetic Voice Rehabilitation After Total Laryngectomy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • University Hospital Leuven
  • Germany
      • Ulm, Germany, 89081
        • Bundeswehr Krankenhaus
  • Netherlands
    • Noord Holland
      • Amsterdam, Noord Holland, Netherlands, 1066 CX
        • Netherlands Cancer Institute
    • Zuid-Holland
      • Rotterdam, Zuid-Holland, Netherlands, 3015GD
        • Erasmus Medical Center
  • Spain
      • Barcelona, Spain, 08025
        • Hospital de la Santa Creu I Sant Pau Universitat Autònoma de Barcelona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
immediate observation during surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 month
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
1 month
Postoperative Results
Time Frame: 1 month
Patients were followed-up one month after surgery.Patients with secondary punctures filled out a questionnaire.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Atos Medical AB

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

January 6, 2010

First Submitted That Met QC Criteria

January 7, 2010

First Posted (Estimate)

January 8, 2010

Study Record Updates

Last Update Posted (Actual)

June 11, 2021

Last Update Submitted That Met QC Criteria

June 3, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UD743_FRITZ_MULTI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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