Neoplasms

All Conditions

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Ear, Nose, and Throat Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

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Pharyngeal Neoplasms

Laryngeal Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Laryngeal Diseases

Respiratory Tract Diseases

Respiratory Tract Neoplasms

Otorhinolaryngologic Diseases

Pharyngeal Diseases

Stomatognathic Diseases

Laryngeal Cancer

The device may be used for patient using another type of voice prosthesis, of for patient undergoing total laryngectomy. This device is definitively placed in two parts:The first one is introduced in the puncture (TEP) through the esophagus (retrograde way). The second part is then clipped on the first one through the tracheotomy orifice (anterograde way).A third part containing the valve can then be clipped in the prosthesis and easily removed in order to change it as often as necessary.

prothesis voice

The second part is then clipped on the first one through the tracheotomy orifice (anterograde way).A third part containing the valve can then be clipped in the prosthesis and easily removed in order to change it as often as necessary.

total laryngectomy

Christian DEBRY, MD

Patrick HEMAR, MD

Philippe SCHULTZ, MD

The benefits of this new material, as demonstrated in animal studies and preliminary studies in man, could provide the answer to problems encountered by surgeons in the field of phonatory implants. This novel application is a step towards resolving the very real problems which still exist in the field today. The functional concept, which will allow better control over integrating implants in tissue, should also, it is hoped, favour cellular colonization, thereby fulfilling a currently unmet medical need. The aim is to avoid well-identified potential complications linked to the use of silicone-only implants (with or without a surface coating), like leakage around the prosthesis (by cellular colonization), and so reduce the risk of protrusion/extrusion of the prosthesis as far as possible, and to avoid trauma to the peri-prosthetic tissues by repeated interventions

Voice Prosthesis Made in Porous Titanium After Total Laryngectomy or Pharyngolaryngectomy

OseoAnvar

Réseau National des Technologies de Santé

University Hospital, Strasbourg, France

pharyngeal repair after total laryngectomy was done by using a linear stapler

pharyngeal repair after total laryngectomy was done by the conventional method (stitching).

pharyngeal repair after total laryngectomy

This study was done to investigate the efficacy and safety of the linear stapler closure of the pharynx after total laryngectomy.

Stapler Versus Conventional Pharyngeal Repair After Total Larygectomy

Linear Stapler Versus Conventional Repair of the Pharynx After Total Laryngectomy: Functional and Oncological Outcomes

to assess the effectiveness of pharyngeal repair and healing without pharyngocutaneous fistula

swallowing was evaluated subjectively by applying the Sydney Swallow Questionnaire, (SSQ) and was evaluated objectively by performing modified barium swallow and functional endoscopic evaluation of swallowing (FEES)

Mansoura University

The current Provox2 voice prosthesis of laryngectomized patients will, when the patient comes in for a change, be replaced with a new, next generation Provox Vega voice prosthesis and insertion system

Provox Vega voice prosthesis (20 Fr)

Frans JM Hilgers, MD, PhD

Michiel WM van den Brekel, MD, PhD

The purpose of this study is to investigate long-term clinical feasibility of a new voice prosthesis and insertion system Provox Vega 20 with SmartInserter) for voice rehabilitation after total laryngectomy. Outcome measures are voice quality, ease of insertion, device life, and reason for replacement.

Long-term Clinical Feasibility of the New Indwelling Provox Vega 20 Voice Prosthesis

Amendment on Phase I Trial NO7VEG 'Assessment of a Next Generation Indwelling Provox Voice Rehabilitation System (Vega)

Device life was measured from the time of insertion until the time of replacement. Reason for replacement was recorded. Only replacements for leakage through the device are considered for calculation of device life time.

Subjective patient opinion about 5 voice related items (intelligibility face to face and on the phone, loudness, pitch and fluency). The best value is 5 and the worst value is 20.

The Vega voice prosthesis used in this study is inserted with a new insertion tool, the SmartInserter. Physicians were asked to rate the insertion on a 4 point scale. what they thought of the new insertion tool, also in comparison to the regular tool used in the clinic, the Provox2 inserter. As the Provox voice prosthesis is a tool physicians already used, no insertions were performed with the Provox2 inserter during the study.

The Netherlands Cancer Institute

Atos Medical AB

Adverse events were assessed after the insertion procedure, upon notification of a problem by the patient, and when the Provox Vega needed replacement. Normal reasons for replacement (leakage through, size changes) were not considered adverse events.

26 Patients who normally use a Provox2 voice prosthesis, were asked to use a new Vega voice prosthesis with an outer diameter of 20 French.

Provox Vega 20

Age, Categorical

Age, Continuous

Sex: Female, Male

Netherlands

Region of Enrollment

Prof. Dr. F.J.M. Hilgers

In 16 out of the 26 patients, the device was replaced for leakage through the device. These 16 devices were considered for calculation of device life time.

Device Life Time

23 patients completed the structured questionnaires about the voice prosthesis. One patient received the wrong voice prosthesis after inclusion. Two patients had unsolvable leakage around the Provox Vega 20, which is 2.5 French smaller in outer diameter than their previous Provox2 voice prosthesis.

Voice Quality

Not difficult at all

A little difficult

Rather difficult

Very difficult

All patients included for insertion evaluation

Ease of Insertion

leakage through prosthesis

periprosthetic leakage due to smaller diameter

combination of causes

1 patient had his Vega inappropriately removed and received a Provox2.

Reason for Replacement

Overall Study

Tracheal Diseases

Hypopharyngeal Cancer

Micronutrients

All Drugs and Chemicals

Silicon

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)

Modified Trans-Esophageal Prosthesis

Vishal US Rao, MS

Satakshi Chatterjee, MS

Sataksi Chatterjee, MS

Sataksi Chaterjee, MS

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.

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.

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.

A Novel Modified Tracheo-Esophageal Voice Prosthesis for Total Laryngectomy Patients

Overall results of the study would be made public but individual patient data would be not be made available

Voice quality would be assessed by a speech therapist using a standardized questionnaire to assess the functionality of the modified TEP

Clinical assessment of modified TEP leak after a test fluid feed

HealthCare Global Enterprise Ltd.

Head, Dept of Head & Neck Surgery

Vasoconstrictor Agents

Respiratory System Agents

Epinephrine

Racepinephrine

Epinephryl borate

The procedure consists of 2 operating times:

* Surgery S1 (1st surgical procedure): total laryngectomy and placement of the stented aortic graft (human tissue + device: NOVATECH GSS TM (trademark) TD), under tracheotomy cover.
* Surgery S2 (2nd surgical procedure) (between S1 +24 weeks and S1 +36 weeks) : opening of the proximal part of the graft by endoscopic way with maintenance of the tracheotomy orifice to ensure patient safety.

Total laryngectomy and reconstruction by stented aortic allograft (using human tissue and device).

Christian DEBRY, MD PhD

Lea FATH, MD

Sait CIFTCI, MD

Philippe SCHULTZ, MD PhD

Idir DJENNAOUI, MD

Patrick HEMAR, MD PhD

Esteban BRENET, MD

The larynx is a cartilaginous organ of the respiratory system located in the throat, which plays an essential role in respiratory function, swallowing and sound production.

In the case of advanced tumours, the surgical option most often remains total laryngectomy, with the corollary of a major impact on quality of life, not so much because of the loss of voice, but because of the presence of a definitive tracheostoma with particularly deleterious consequences.

The majority of the work of the different teams around the world has focused on restoring phonatory function, but no technique - apart from the artificial larynx developed in the ENT department of the Hautepierre Hospital - has yet succeeded in removing the tracheotomy orifice, requiring the restoration of a common passage between the respiratory and swallowing passages. If nutrition and phonatory function can still be supplemented after such an operation (oesophageal rehabilitation, implant placed between the trachea and oesophagus), natural breathing is no longer possible. Patients are forced to wear a permanent tracheotomy opening.

There are currently only 2 ways to try to restore all the functions of the larynx after total laryngectomy: i) laryngeal transplantation, but this procedure requires maintaining immunosuppressive treatment, which is not possible in patients suffering from cancer of the larynx, which is not a vital organ, ii) artificial larynx made of biomaterials (titanium), the first cases of which were performed worldwide in the ENT department of the Strasbourg University Hospital in 2012, results published in the NEJM (API 2008-2009 HUS No. 4493- IDRCB No.: 2011-A00032-39. However, difficulties were encountered with the use of the titanium prosthesis due to the bulk and rigidity of the removable and non-removable part, which caused residual swallowing difficulties (false routes).

It is now possible, due to the development of new allograft techniques in humans for tracheal replacement (studies published on a large number of cases with several years of hindsight, cf. references), to switch to the "all biological" using an aortic graft stented with a silicone stent. We wish to use these grafts in laryngeal restoration after total laryngectomy by our team, while exploiting all the data and experience acquired (unique in the world) within the ENT department of Hautepierre Hospital. This new conceptual leap should make it possible to significantly improve the patient's quality of life and the performance previously acquired in clinical trials on the artificial larynx in its entirety (breathing, phonation) or partially (swallowing).

The investigators thus propose to evaluate this new artificial larynx in aortic allograft, the objective of which is to supplement the respiratory, swallowing and phonation functions in patients laryngectomized for carcinological causes.

Aortic Laryngeal Rehabilitation Graft

Placement of a Laryngeal Allograft Aortic Implant After Total Laryngectomy to Rehabilitate Laryngeal Function

The primary endpoint is composite, combining clinically assessments:

* the score on the Respiratory Function Assessment (clinically assessed : 0: no dyspnea, to 3 (major dyspnea) and
* the score (0-3) on the Swallowing Ability Assessment (0: no issue to 3: major food misdirection) assessed by nasofibroscopy.

The procedure will be considered a success if :

* respiratory function: no dyspnea (score=0) or moderate dyspnea (score=1) AND
* swallowing ability: no false-route (score=0) or moderate false-route (score=1)

In all other cases, the procedure will be considered a failure.

Score on the Respiratory Function Assessment (clinically assessed : 0: no dyspnea, to 3 (major dyspnea)

Score (0-3) on the Swallowing Ability Assessment (0: no issue to 3: major food misdirection) assessed by nasofibroscopy.

The Voice Handicap Index is a scale where the patient grades the severity of his disorder by 10 items on a scale from 0 (never) to 4 (always). Close to 0 may consider that the disability is almost nil, close to 120 the patient's voice has a significant impact on his or her daily life.

Etablissement Français du Sang

Participants will be fitted to use a hand free HME device over their stoma in order to communicate with a voice prosthesis for one month. The participants will also serve as their own control performing voicing and speech tasks using digital occlusion and digital depression HME.

A voice prosthesis, SpeakFree HME Hands Free Valve, achieved with creation of a tracheoesophageal puncture will be placed over the stoma for 1 month.

SpeakFree HME Hands Free Valve

Using participant's own fingers, they will be putting their fingers over the stoma.

Digital Occlusion

A digital handheld press-down HME will be placed over stoma.

Digital Depression HME

Jerri Halgowich

Mario A Landera, SLP.D.

The purpose of the study is to evaluate the new Blom-Singer SpeakFree disposable hands free valve heat and moisture exchanger (HME). The investigators will compare the SpeakFree to other modalities of stomal occlusion (digital occlusion and digital depression of an HME) for patients who communicate with a voice prosthesis as determined by patient preference and satisfaction. In addition, the investigators will compare the SpeakFree to other modalities of stomal occlusion as determined by objective measures of speech and voice parameters (maximum phonation time, syllables per breath, minimum/maximum phonation pressures, and a clinician rating of voice quality using a visual analog scale).

SpeakFree Heat and Moisture Exchanger (HME)

Evaluation of a Disposable Hands-Free Heat and Moisture Exchanger (HME) Valve: The Blom-Singer SpeakFree HME Hands Free Valve

Patient preference and satisfaction will be measured using a visual Analog Scale (VAS) ranging in score from 1-10 with a higher score indicating greater satisfaction with the device.

Voice Quality will be measured using a visual Analog Scale ranging in score from 1-10 with a higher score indicating that the patient feels their voice quality is better with the device.

Maximum phonation time (MPT) is a clinical measurement of the longest time a person can phonate a vowel in seconds.

Participants' number of syllables per breath while reading a standardized reading passage will be measured and reported.

Minimal and maximal pressures will be reported using a manometer while the participant counts from 1 to 15.

The clinician will rate participant's voice quality using VAS. VAS has a total score ranging from 1 to 10 with the higher score indicating that the clinician feels that participant's voice quality is better with the device.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Voice Prosthesis Made in Porous Titanium After Total Laryngectomy or Pharyngolaryngectomy	NCT00396617	Pharyngeal Neop... Laryngeal Neopl... Carcinoma	prothesis voice total laryngect...	18 Years -	University Hospital, Strasbourg, France
Stapler Versus Conventional Pharyngeal Repair After Total Larygectomy	NCT06256263	Malignant Tumor...	total laryngect...	-	Mansoura University
Long-term Clinical Feasibility of the New Indwelling Provox Vega 20 Voice Prosthesis	NCT00661570	Total Laryngect...	Provox Vega voi...	-	Atos Medical AB
A Novel Modified Tracheo-Esophageal Voice Prosthesis for Total Laryngectomy Patients	NCT03039465	Laryngeal Cance... Hypopharynx Can...	Modified Trans-...	-	HealthCare Global Enterprise Ltd.
Aortic Laryngeal Rehabilitation Graft	NCT04650919	Laryngeal Cance... Total Laryngect...	Total laryngect...	18 Years -	University Hospital, Strasbourg, France
SpeakFree Heat and Moisture Exchanger (HME)	NCT05349487	Laryngeal Cance... Laryngectomy	SpeakFree HME H... Digital Occlusi... Digital Depress...	18 Years -	University of Miami
SpeakFree Heat and Moisture Exchanger (HME)	NCT05349487	Laryngeal Cance... Laryngectomy	SpeakFree HME H... Digital Occlusi... Digital Depress...	18 Years -	University of Miami
Long-term Clinical Feasibility of the New Indwelling Provox Vega 20 Voice Prosthesis	NCT00661570	Total Laryngect...	Provox Vega voi...	-	Atos Medical AB
Voice Prosthesis Made in Porous Titanium After Total Laryngectomy or Pharyngolaryngectomy	NCT00396617	Pharyngeal Neop... Laryngeal Neopl... Carcinoma	prothesis voice total laryngect...	18 Years -	University Hospital, Strasbourg, France

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