Clinical trial · Interventional
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
NCT01045057CI-TRIAL-00052217completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Larynx Cancer | Malignant Laryngeal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Puncture Set and Flexible Protector | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Puncture Set and Flexible Protector
- description
- Provox Vega Puncture Set is used to create the primary puncture and insert the prosthesis during total laryngectomy
- interventionNames
- Device: Puncture Set and Flexible Protector
Primary outcomes (1)
- measure
- Success Rate of Procedure
- timeFrame
- immediate observation during surgery
- description
- As successful counted all successful procedures in which the tracheal flange of the voice prosthesis unfolded completely without help of additional tools. A success rate of 80% and higher was considered acceptable.
Secondary outcomes (3)
- measure
- Satisfaction of Physician
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.