Clinical testing of a low cost speech device for throat cancer patients

Clinical validation of indigenous low cost silicon devices for persons with laryngectomy

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/02/040558

Enrollment

Registered

2022-02-23

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C320- Malignant neoplasm of glottis Health Condition 2: C329- Malignant neoplasm of larynx, unspecified Health Condition 3: C328- Malignant neoplasm of overlappingsites of larynx Health Condition 4: C322- Malignant neoplasm of subglottis Health Condition 5: C321- Malignant neoplasm of supraglottis

Interventions

Intervention1: Voice prosthesis and larytube for persons post-laryngectomy: A newly indigenously developed medical grade silicon based voice prosthesis and larytube which has undergone Industrial leve

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion Criteria: 1.For Voice prosthesis: Tracheoesophageal speakers (minimum 1-month post-surgery) 2.For Lary Tube: Individuals post total Laryngectomy (Minimum 1 month post-surgery)

Exclusion criteria

Exclusion criteria: Exclusion Criteria: 1.Individuals above 80 years of age 2.Individuals with dexterity issues 3.Individuals with vision problems 4.History of any neurological, psychiatric, or psychological ailments

Design outcomes

Primary

Measure	Time frame
1.Clinical outcomes a.Voice MPD Pitch Loudness Voice quality b.speech Intelligibility rating scale Counts per breath c.swallowing Difficulty with food consistencies Feeling of food getting stuck AspirationTimepoint: 1: With commercial voice prosthesis 2: immediately post fitting of indigenous voice prosthesis 3: After 15 days of use of indigenous voice prosthesis 4: After 1 month of use of indigenous voice prosthesis	—

Measure

Time frame

1.Clinical outcomes a.Voice MPD Pitch Loudness Voice quality b.speech Intelligibility rating scale Counts per breath c.swallowing Difficulty with food consistencies Feeling of food getting stuck AspirationTimepoint: 1: With commercial voice prosthesis 2: immediately post fitting of indigenous voice prosthesis 3: After 15 days of use of indigenous voice prosthesis 4: After 1 month of use of indigenous voice prosthesis

—

Secondary

Measure	Time frame
1.Device related outcomes Type of voice prosthesis-Dimensions Cost of Device Durability (duration of usage without leakage related issues) Ease of fitting Leakage issues Discoloration /damage Timepoint: 1: With commercial voice prosthesis 2: immediately post fitting of indigenous voice prosthesis 3: After 15 days of use of indigenous voice prosthesis 4: After 1 month of use of indigenous voice prosthesis	—

Measure

Time frame

1.Device related outcomes Type of voice prosthesis-Dimensions Cost of Device Durability (duration of usage without leakage related issues) Ease of fitting Leakage issues Discoloration /damage Timepoint: 1: With commercial voice prosthesis 2: immediately post fitting of indigenous voice prosthesis 3: After 15 days of use of indigenous voice prosthesis 4: After 1 month of use of indigenous voice prosthesis

—

Countries

India

Contacts

Public ContactDrVenkataraja Aithal U

Manipal College of Health Professions, MAHE,

vrajaithal@manipal.edu9380495415

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026