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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 ID: NCT01045057
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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University Hospital Leuven, Leuven, , Belgium
Bundeswehr Krankenhaus, Ulm, , Germany
Netherlands Cancer Institute, Amsterdam, Noord Holland, Netherlands
Erasmus Medical Center, Rotterdam, Zuid-Holland, Netherlands
Hospital de la Santa Creu I Sant Pau Universitat Autònoma de Barcelona, Barcelona, , Spain
Name: Frans JM Hilgers, MD, PhD
Affiliation: The Netherlands Cancer Institute
Role: PRINCIPAL_INVESTIGATOR