N/A
N=27
Clinical Feasibility of New Tracheoesophageal Puncture Set
Larynx Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01045057 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Feb 2015
Primary outcome: Primary: Success Rate of Procedure — 23 Nr part. with succesful insertions
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Puncture Set and Flexible Protector (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Atos Medical AB
- Primary completion
- Mar 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Success Rate of Procedure |
23 | — |
| SECONDARY Satisfaction of Physician |
26 | — |
| SECONDARY Cost Effectiveness Calculation |
155.4 | — |
| SECONDARY Postoperative Results |
6; 6 | — |
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.
Eligibility Criteria
Inclusion Criteria
- primary puncture during total laryngectomy
- secondary puncture some time after total laryngectomy
Exclusion Criteria
- anatomical abnormalities that prevent appropriate pharynx protection during secondary puncture
- not eligible to use a voice prosthesis for other reasons
Data sourced from ClinicalTrials.gov (NCT01045057). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.