Clinical trial · Interventional
A Novel Modified Tracheo-Esophageal Voice Prosthesis for Total Laryngectomy Patients
- 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)
This study is being conducted at Healthcare Global Enterprises Ltd to evaluate the role of a novel Tracheo-Esophageal voice Prosthesis for total laryngectomy +/- partial pharyngectomy patients. 30 patients will be enrolled as an inpatient or outpatient. Patients who are planned to undergo total laryngectomy +/- pharyngectomy surgery and trachea-esophageal puncture procedure.(for primary TEP insertion) or patients who have undergone total laryngectomy \> 6weeks prior and are suitable candidates for secondary TEP insertion would be recruited to the study. Insertion of the TEP will be done in primary setting or secondary setting. Patients, who are undergoing primary TEP insertion, will be evaluated for speech/ voice at an interval of 6 weeks, 12 weeks and 6 months after the procedure. Patients who are undergoing secondary TEP insertion to be evaluated on the same day of the procedure along with evaluation at an interval of 6 weeks, 12 weeks and 6 months. All the patients will be evaluated clinically for a fluid leak (through and around the TEP) on the same days of voice analysis by giving test feeds under supervision.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hypopharynx Cancer | Malignant Hypopharyngeal Neoplasm | ALIAS | 0.90 |
| Laryngeal Cancer | Malignant Laryngeal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Modified Trans-Esophageal Prosthesis | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Modified Trans-Esophageal Prosthesis
- description
- Patients satisfying the selection criteria would be subjected to the insertion of the TEP and evaluated at subsequent time points for the success of the procedure.
- interventionNames
- Device: Modified Trans-Esophageal Prosthesis
Primary outcomes (2)
- measure
- Change in Voice Quality
- timeFrame
- Assessments would be done 6 weeks, 12 weeks and 6 months post surgery
- description
- Voice quality would be assessed by a speech therapist using a standardized questionnaire to assess the functionality of the modified TEP
- measure
- Change in Presence / Absence of Fluid Leak
- timeFrame
- Immediately, 6 weeks, 12 weeks and 6 months after the Modified TEP insertion procedure
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Patients who are surgically and medically fit for undergoing a total laryngectomy +/- partial pharyngectomy. * Patients who have already undergone total laryngectomy +/- partial pharyngectomy and are willing for a secondary voice rehabilitation procedure. * Patient signing the informed consent for procedure after understanding the details Exclusion Criteria: * Partial laryngectomy * Near total laryngectomy * Patient unfit for the procedure * Patients not consenting for the procedure * Patients utilizing alternative ways of post laryngectomy voice rehabilitation (for secondary insertion) * Patients with stricture in pharynx (for secondary insertion) * Partial pharyngectomy reconstruction, not permitting insertion of TEP
References
Publications (0)
Data not yet available