A study to assess speech quality using AUM voice prosthesis.

Phase 4

• Conditions: Health Condition 1: J383- Other diseases of vocal cords

• Registration Number: CTRI/2021/08/036007
• Lead Sponsor: Social Alpha

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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) <=2.

4. Available for follow-up for the duration of the study.

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified