NL-OMON38672
Completed
N/A
Early clinical feasibility study of a new voice prosthesis: the Provox Vega HP - Provox Vega HP study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- 'total laryngectomy' 'voice rehabilitation'
- Sponsor
- Atos Medical AB
- Enrollment
- 16
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Laryngectomized patients using either the Provox Vega or the Provox ActiValve Light voice prosthesis, with a length of 6, 8, or 10 mm
- •Age: 18 years or older
Exclusion Criteria
- •\-Current tracheoesophageal puncture problems such as enlarged puncture or infection
- •\-Active recurrent or metastatic disease (medical deterioration)
- •\-Unable to understand the patient information and/or unable to give informed consent
Outcomes
Primary Outcomes
Not specified
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