Health Condition 1: J383- Other diseases of vocal cords
Conditions
Interventions
Intervention1: AUM ® tracheo-esophageal voice prosthesis: Platinum cured medical grade silicone based tracheoesophageal voice prosthesis (AUM ® ) with a
single valve mechanism. The device is radio l
Sponsors
Social Alpha
Eligibility
Inclusion criteria
Inclusion criteria: 1. Life expectancy >=10 months. 2. Surgically and medically fit for undergoing a total laryngectomy ± partial phrenectomy, or had already undergone total laryngectomy ± partial phrenectomy >=6weeks prior and were willing for a secondary voice rehabilitation procedure. 3. Eastern Cooperative Oncology Group (ECOG) performance status (ECOG) 4. Available for follow-up for the duration of the study.
Exclusion criteria
Exclusion criteria: 1. Known allergy or expected hypersensitivity in the opinion of the investigator. 2. Patients with partial laryngectomy, near-total laryngectomy, utilizing alternative ways of post-laryngectomy voice rehabilitation (for secondary insertion). 3. Patients with total laryngo-pharyngectomy with gastric pull up not permitting insertion of Tracheoesophageal prosthesis (TEP) 4. Aphonia 5. Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements. 6. Any specific condition that in the judgment of the investigator precludes participation because it could affect Patient safety. 7. Pregnant women or lactating Mother
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Voice quality.(Speech Intelligibitly score (AYJNISHD (D) SIRS)) Timepoint: -10 to Day 0, Day 1, Day 30 ± 2 days, Day 60 ± 2 days, Day 90 ± 4 days, Day 120 ± 4 days, Day 150 ± 4 days and Day 180 ± 5 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To assess leak (no leak/ peri-prosthesis leak/ intra-prosthesis leak) by clinically by expert 2.Any breakage or damage prohibiting it from functioning. 3. Adverse events and serious adverse events recording Timepoint: 1. -10 to Day 0, Day 1, Day 30 ± 2 days, Day 60 ± 2 days, Day 90 ± 4 days, Day 120 ± 4 days, Day 150 ± 4 days and Day 180 ± 5 days. 2. Throughout the duration of the study. 3. Throughout the duration of the study. | — |
Countries
India
Contacts
Public ContactMeena Dalal
HCG Cancer Hospital
Outcome results
None listed