At a glance
ClinicalIndex Comparison RecordN/ACompleted· 27 enrolled
Drug / intervention
Puncture Set and Flexible Protectordevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Clinical Feasibility of a New Surgical Tool for Primary or Secondary Tracheoesophageal Puncture and Voice Prosthesis Insertion for Prosthetic Voice Rehabilitation After Total Laryngectomy
In Brief
A clinical study evaluating Puncture Set and Flexible Protector for Larynx Cancer. Completed, enrolled 27 participants across 5 sites in 4 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLarynx Cancer
CountriesBelgium, Germany, Netherlands, Spain
Collaborators--
Timeline
N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartDec 2009
First PostedJan 2010
Primary CompletionMar 2011
Study CompletionApr 2011
TodayJul 2026
First PostedJan 8, 2010
Enrollment StartDec 1, 2009
Primary CompletionMar 1, 2011
Study CompletionApr 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 16.5 years ago
Interventions
Puncture Set and Flexible Protectordevice
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.