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OpenTrials
Completed

NCT Number: NCT01045057

Clinical Feasibility of New Tracheoesophageal Puncture Set

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.

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Key information

Conditions

Larynx Cancer Head and Neck Neoplasms Laryngeal Diseases Laryngeal Neoplasms Neoplasms Neoplasms by Site Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Leuven, Leuven, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Puncture Set and Flexible Protector

Device

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Atos Medical AB

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jan 8, 2010
Registry last updated
Jun 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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