A Novel Modified Tracheo-Esophageal Voice Prosthesis for Total Laryngectomy Patients (TEP)
Primary Purpose
Laryngeal Cancer, Hypopharynx Cancer
Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Modified Trans-Esophageal Prosthesis
Sponsored by
About this trial
This is an interventional supportive care trial for Laryngeal Cancer focused on measuring Indwelling Trachea-oesophageal Prosthesis, Voice Rehabilitation, Total Laryngectomy
Eligibility Criteria
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
Sites / Locations
- HealthCare Global Enterprises LtdRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Modified Trans-Esophageal Prosthesis
Arm 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.
Outcomes
Primary Outcome Measures
Change in Voice Quality
Voice quality would be assessed by a speech therapist using a standardized questionnaire to assess the functionality of the modified TEP
Change in Presence / Absence of Fluid Leak
Clinical assessment of modified TEP leak after a test fluid feed
Secondary Outcome Measures
Full Information
NCT ID
NCT03039465
First Posted
January 27, 2017
Last Updated
January 30, 2017
Sponsor
HealthCare Global Enterprise Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03039465
Brief Title
A Novel Modified Tracheo-Esophageal Voice Prosthesis for Total Laryngectomy Patients
Acronym
TEP
Official Title
A Novel Modified Tracheo-Esophageal Voice Prosthesis for Total Laryngectomy Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 18, 2016 (Actual)
Primary Completion Date
December 31, 2017 (Anticipated)
Study Completion Date
December 31, 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
HealthCare Global Enterprise Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laryngeal Cancer, Hypopharynx Cancer
Keywords
Indwelling Trachea-oesophageal Prosthesis, Voice Rehabilitation, Total Laryngectomy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A single group of patients undergoing the insertion of the prosthesis would be evaluated for voice quality and fluid leak as a measure of success of the intervention.
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Modified Trans-Esophageal Prosthesis
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Modified Trans-Esophageal Prosthesis
Intervention Description
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)
Primary Outcome Measure Information:
Title
Change in Voice Quality
Description
Voice quality would be assessed by a speech therapist using a standardized questionnaire to assess the functionality of the modified TEP
Time Frame
Assessments would be done 6 weeks, 12 weeks and 6 months post surgery
Title
Change in Presence / Absence of Fluid Leak
Description
Clinical assessment of modified TEP leak after a test fluid feed
Time Frame
Immediately, 6 weeks, 12 weeks and 6 months after the Modified TEP insertion procedure
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vishal US Rao, MS
Phone
9739774949
Email
drvishalrao@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Satakshi Chatterjee, MS
Phone
8971966903
Email
sataksis2007@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vishal US Rao, MS
Organizational Affiliation
Dept of Head & Neck Surgery, HealthCare Global Enterprises Ltd.
Official's Role
Principal Investigator
Facility Information:
Facility Name
HealthCare Global Enterprises Ltd
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560027
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vishal US Rao, MS
Phone
00919739774949
Email
drvishalrao@yahoo.com
First Name & Middle Initial & Last Name & Degree
Sataksi Chatterjee, MS
Phone
00918971966903
Email
sataksis2007@gmail.com
First Name & Middle Initial & Last Name & Degree
Sataksi Chaterjee, MS
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Overall results of the study would be made public but individual patient data would be not be made available
Learn more about this trial
A Novel Modified Tracheo-Esophageal Voice Prosthesis for Total Laryngectomy Patients
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