- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03039465
A Novel Modified Tracheo-Esophageal Voice Prosthesis for Total Laryngectomy Patients (TEP)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study is being conducted at Healthcare Global Enterprises Ltd to evaluate the role of a novel trachea-oesophageal 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 fluid leak (through and around the TEP) on the same days of voice analysis by giving test feeds under supervision.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Vishal US Rao, MS
- Phone Number: 9739774949
- Email: drvishalrao@yahoo.com
Study Contact Backup
- Name: Satakshi Chatterjee, MS
- Phone Number: 8971966903
- Email: sataksis2007@gmail.com
Study Locations
-
-
Karnataka
-
Bangalore, Karnataka, India, 560027
- Recruiting
- Healthcare Global Enterprises Ltd
-
Contact:
- Vishal US Rao, MS
- Phone Number: 00919739774949
- Email: drvishalrao@yahoo.com
-
Contact:
- Sataksi Chatterjee, MS
- Phone Number: 00918971966903
- Email: sataksis2007@gmail.com
-
Sub-Investigator:
- Sataksi Chaterjee, MS
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Modified Trans-Esophageal Prosthesis
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.
|
This device is a biomedical grade silicon voice prosthesis with an inner esophageal flange, a stem and an outer tracheal flange.
Insertion would be done through a modified 'romovac' inserter set / curved metal inserter (provided with the TEP) and an oesophagoscope in case of secondary insertion would be used.
in patients with existing TEP puncture / who require a TEP change, on out-patient basis, the insertion would be done with a novel two-part inserter device (front loading)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Voice Quality
Time Frame: Assessments would be done 6 weeks, 12 weeks and 6 months post surgery
|
Voice quality would be assessed by a speech therapist using a standardized questionnaire to assess the functionality of the modified TEP
|
Assessments would be done 6 weeks, 12 weeks and 6 months post surgery
|
Change in Presence / Absence of Fluid Leak
Time Frame: Immediately, 6 weeks, 12 weeks and 6 months after the Modified TEP insertion procedure
|
Clinical assessment of modified TEP leak after a test fluid feed
|
Immediately, 6 weeks, 12 weeks and 6 months after the Modified TEP insertion procedure
|
Collaborators and Investigators
Investigators
- Principal Investigator: Vishal US Rao, MS, Dept of Head & Neck Surgery, HealthCare Global Enterprises Ltd.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HCG/SX/003/2016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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