Trials / Completed
CompletedNCT01045057
Clinical Feasibility of New Tracheoesophageal Puncture Set
Clinical Feasibility of a New Surgical Tool for Primary or Secondary Tracheoesophageal Puncture and Voice Prosthesis Insertion for Prosthetic Voice Rehabilitation After Total Laryngectomy
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 27 (actual)
- Sponsor
- Atos Medical AB · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2009-12-01
- Primary completion
- 2011-03-01
- Completion
- 2011-04-01
- First posted
- 2010-01-08
- Last updated
- 2021-06-11
- Results posted
- 2015-02-10
Locations
5 sites across 4 countries: Belgium, Germany, Netherlands, Spain
Source: ClinicalTrials.gov record NCT01045057. Inclusion in this directory is not an endorsement.