Clinical Feasibility of New Tracheoesophageal Puncture Set
|ClinicalTrials.gov Identifier: NCT01045057|
Recruitment Status : Completed
First Posted : January 8, 2010
Results First Posted : February 10, 2015
Last Update Posted : February 27, 2015
|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)|
|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|
|Primary Completion Date :||March 2011|
|Study Completion Date :||April 2011|
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.
- 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.
- 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.
- 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
- Postoperative Results [ Time Frame: 1 month ]Patients were followed-up one month after surgery.Patients with secondary punctures filled out a questionnaire.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01045057
|University Hospital Leuven|
|Leuven, Belgium, 3000|
|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|
|Principal Investigator:||Frans JM Hilgers, MD, PhD||The Netherlands Cancer Institute|