NL-OMON50825
Completed
N/A
Early clinical feasibility study of a new voice prosthesis: the Provox Vega HP - Vega HP study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Atos Medical AB
- Enrollment
- 20
- 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 22\.5 or the Provox
- •ActiValve Light voice prosthesis, with a length of 4, 6, 8, or 10 mm
- •18 years and older
Exclusion Criteria
- •Current tracheoesophageal puncture problems such as enlarged puncture or
- •Active recurrent or metastatic disease (medical deterioration)
- •The use of ActiValve Strong/XtraStrong or XtraSeal
- •Unable to understand the Patient Information and/or unable to give Informed
Outcomes
Primary Outcomes
Not specified
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