Back to resultsClinical Feasibility of New Tracheoesophageal Puncture Set
Primary Purpose
Larynx Cancer
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Puncture Set and Flexible Protector
Sponsored by
About this trial
This is an interventional treatment trial for Larynx Cancer focused on measuring voice prosthesis, larynx cancer, laryngectomy
Eligibility 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
Sites / Locations
- University Hospital Leuven
- Bundeswehr Krankenhaus
- Netherlands Cancer Institute
- Erasmus Medical Center
- Hospital de la Santa Creu I Sant Pau Universitat Autònoma de Barcelona
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Puncture Set and Flexible Protector
Arm Description
Provox Vega Puncture Set is used to create the primary puncture and insert the prosthesis during total laryngectomy
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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
Postoperative Results
Patients were followed-up one month after surgery.Patients with secondary punctures filled out a questionnaire.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01045057
Brief Title
Clinical Feasibility of New Tracheoesophageal Puncture Set
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 Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Atos Medical AB
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Larynx Cancer
Keywords
voice prosthesis, larynx cancer, laryngectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Provox Vega Puncture Set
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Puncture Set and Flexible Protector
Arm Type
Experimental
Arm Description
Provox Vega Puncture Set is used to create the primary puncture and insert the prosthesis during total laryngectomy
Intervention Type
Device
Intervention Name(s)
Puncture Set and Flexible Protector
Intervention Description
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 Measure Information:
Title
Success Rate of Procedure
Description
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.
Time Frame
immediate observation during surgery
Secondary Outcome Measure Information:
Title
Satisfaction of Physician
Description
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.
Time Frame
1 month
Title
Cost Effectiveness Calculation
Description
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
Time Frame
1 month
Title
Postoperative Results
Description
Patients were followed-up one month after surgery.Patients with secondary punctures filled out a questionnaire.
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frans JM Hilgers, MD, PhD
Organizational Affiliation
The Netherlands Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Bundeswehr Krankenhaus
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Netherlands Cancer Institute
City
Amsterdam
State/Province
Noord Holland
ZIP/Postal Code
1066 CX
Country
Netherlands
Facility Name
Erasmus Medical Center
City
Rotterdam
State/Province
Zuid-Holland
ZIP/Postal Code
3015GD
Country
Netherlands
Facility Name
Hospital de la Santa Creu I Sant Pau Universitat Autònoma de Barcelona
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Clinical Feasibility of New Tracheoesophageal Puncture Set
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