Laryngeal CancerTEPNCT03039465
A Novel Modified Tracheo-Esophageal Voice Prosthesis for Total Laryngectomy Patients
A study testing Modified Trans-Esophageal Prosthesis in people with Laryngeal Cancer and Hypopharynx Cancer, run by HealthCare Global Enterprise Ltd. at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Laryngeal Cancer, Hypopharynx Cancer
- What is being tested?
- Modified Trans-Esophageal Prosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- 18 Apr 2016to 31 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
HealthCare Global Enterprises Ltd
Bangalore, Karnataka, 560027
Vishal US Rao, MS, 00919739774949, drvishalrao@yahoo.com
Sataksi Chatterjee, MS, 00918971966903, sataksis2007@gmail.com
About this study
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.
Read the 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.
- Conditions
- Laryngeal Cancer, Hypopharynx Cancer
- Being tested
- Modified Trans-Esophageal Prosthesis
- Keywords
- Indwelling Trachea-oesophageal Prosthesis, Voice Rehabilitation, Total Laryngectomy
- Medical subject headings
- Laryngeal Neoplasms, Hypopharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Trans-Esophageal ProsthesisDevice
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)
| Study group | Role | What they receive |
|---|---|---|
| Modified Trans-Esophageal Prosthesis | Experimental | 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. Receives: Device: Modified Trans-Esophageal Prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Assessments would be done 6 weeks, 12 weeks and 6 months post surgery
Change in Presence / Absence of Fluid Leak
Clinical assessment of modified TEP leak after a test fluid feed
Measured: Immediately, 6 weeks, 12 weeks and 6 months after the Modified TEP insertion procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2017 (estimated)
- Study start18 Apr 2016
- Primary completion31 Dec 2017 (estimated)
- Study completion31 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laryngeal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HealthCare Global Enterprise Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Vishal U S Rao, HealthCare Global Enterprise Ltd.
- Investigators
- Vishal US Rao, MS, Principal investigator, Dept of Head & Neck Surgery, HealthCare Global Enterprises Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03039465
- Sponsor's protocol ID
- HCG/SX/003/2016
- Acronym
- TEP
- Status last verified
- Jan 2017
- First submitted
- 27 Jan 2017
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Overall results of the study would be made public but individual patient data would be not be made available
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Modified Tracheo-Esophageal Voice Prosthesis for Total Laryngectomy Patients
- ClinicalTrials.gov ID
- NCT03039465
- Acronym / sponsor ID
- TEP / HCG/SX/003/2016
- Conditions
- Laryngeal Cancer, Hypopharynx Cancer
- Keywords
- Indwelling Trachea-oesophageal Prosthesis, Voice Rehabilitation, Total Laryngectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- HealthCare Global Enterprise Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Apr 2016 (actual)
- Primary completion
- 31 Dec 2017 (estimated)
- Study completion
- 31 Dec 2017 (estimated)
- First posted
- 1 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Modified Trans-Esophageal Prosthesis | Experimental | Device: Modified Trans-Esophageal ProsthesisPatients 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified Trans-Esophageal ProsthesisThis 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) | Device | Modified Trans-Esophageal Prosthesis |
Primary outcome
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
- Individual participant dataSharing planned: No. Overall results of the study would be made public but individual patient data would be not be made available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vishal US Rao, MS principal investigator
Dept of Head & Neck Surgery, HealthCare Global Enterprises Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Trans-Esophageal Prosthesis in people with Laryngeal Cancer and Hypopharynx Cancer, run by HealthCare Global Enterprise Ltd. at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vishal US Rao, MS (9739774949, drvishalrao@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Voice Quality (time frame: Assessments would be done 6 weeks, 12 weeks and 6 months post surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2017.