Clinical trials: Total Laryngectomy
Laryngeal Cancer, Laryngectomy
SpeakFree Heat and Moisture Exchanger (HME)
The purpose of the study is to evaluate the new Blom-Singer SpeakFree disposable hands free valve heat and moisture exchanger (HME).
- Trial name
- SPEAKFREE (NCT05349487)
- Testing
- SpeakFree HME Hands Free Valve, Digital Occlusion, Digital Depression HME
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- University of Miami
Total Laryngectomy
ENTegral Artificial Larynx Clinical Trial
The objective of this clinical study is to evaluate the feasibility, safety and efficacy of the ENTegral Artificial Larynx (AL) in patients indicated for total laryngectomy.
- Trial name
- NCT01948219
- Testing
- ENTegral Artificial Larynx implant
- Where
- 3 sites in Belgium, France
- Volunteers
- 2 people
- Sponsor
- ProTiP Medical
Total Laryngectomy
Long-term Clinical Feasibility of the New Indwelling Provox Vega 20 Voice Prosthesis
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.
- Trial name
- NCT00661570
- Testing
- Provox Vega voice prosthesis (20 Fr)
- Where
- Netherlands
- Volunteers
- 26 people
- Sponsor
- Atos Medical AB
Total Laryngectomy
Pre-operative Counselling in Laryngectomized Patients
The investigators aim to verify the effects of pre-operative Speech-Language Pathology (SLP) counselling on patients undergoing total laryngectomy in terms of levels of distress, post-traumatic stress symptoms, anxious-depressive…
- Trial name
- NCT04491487
- Testing
- pre-operative counselling
- Where
- Italy
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Laryngectomy; Status
Pilot Feasibility Study of Peristomal Adhesives
Loss of voice is one of the greater consequences of total laryngectomy. The voice prosthesis allows the patients to speak again in a very short time but forces them to use one hand when speaking.
- Trial name
- NCT05762497
- Testing
- Moldable adhesive
- Where
- Italy
- Volunteers
- 10 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Laryngectomy, Total Pharyngo-laryngectomy
Correlation Between Personnality Traits and Ability to Learn Oroesophageal Voice
After total laryngectomy and loss of laryngeal phonation, the oro-oesophageal voice (VOO) is a communication option for the patient.
- Trial name
- CoPerVOO (NCT06856863)
- Testing
- Test of personality : questionnary
- Where
- France
- Volunteers
- 40 people
- Sponsor
- Assistance Publique Hopitaux De Marseille
Laryngectomy
Cost-effectiveness Analysis of Vocal Rehabilitation With Strengthened Tracheoesophageal Voice Implant Prosthesis Versus Standard Voice Prosthesis in Case of Repeated Intra-prosthetic Leakage After Total Laryngectomy
The purpose of this study is to determine the cost-effectiveness of vocal rehabilitation with reinforced inter-tracheoesophageal voice prosthesis versus standard voice prosthesis in case of repeated intra-prosthetic leakage in…
- Trial name
- PHRASAL (NCT04100954)
- Testing
- Reinforced prosthesis, Standard prosthesis
- Where
- 13 sites in France
- Volunteers
- 81 people
- Sponsor
- Nantes University Hospital
Cognitive Aging, Hyposmia
Mechanical and Sensorial Training in the Olfactive Rehabilitation of Patients With Total Laryngectomy
To assess the efficacy of two olfactory rehabilitation protocols (Nasal Airflow-Inducing Maneuver (NAIM) with or without ol-factory training) on olfactory function (sniffing stick test) and quality of life (questionnaire Self-MOQ…
- Conditions
- Cognitive Aging, Hyposmia, Total Laryngectomy
- Trial name
- OLFAC-TL (NCT07122037)
- Testing
- DosMedical Smell Training Set, Nasal Airflow Inducing Maneuver
- Where
- Belgium
- Volunteers
- 16 people
- Sponsor
- University Hospital of Mont-Godinne
Larynx Cancer
Clinical Feasibility of New Tracheoesophageal Puncture Set
During a total laryngectomy a puncture is created in the tracheoesophageal wall and a voice prosthesis is inserted. With this voice prosthesis the patient learns to speak again.
- Trial name
- NCT01045057
- Testing
- Puncture Set and Flexible Protector
- Where
- 5 sites in Belgium, Germany and 2 more
- Volunteers
- 27 people
- Sponsor
- Atos Medical AB
Total Laryngectomy
Laryngectomy Education
Patients undergoing total laryngectomy are at high risk for 30-day unplanned readmission. Many of these readmissions are related to stomal care, and it is thought that the readmissions could be prevented with better patient and…
- Trial name
- NCT02601638
- Testing
- Demographics and Health History Questionnaire, Pre-Class Laryngectomy Survey, Counseling session with speech pathologist
- Where
- United States
- Volunteers
- 55 people
- Sponsor
- Washington University School of Medicine
Laryngeal and Hypopharyngeal Tumors
Study Title: Oncological and Functional Results After Total Laryngectomy and Pharyngolaryngectomy
Salvage total laryngectomy (TL) and total pharyngolaryngectomy (TPL) are the gold standard for most recurrent laryngeal and hypopharyngeal tumors as well as in patients with contraindication for chemoradiotherapy (CRT).
- Trial name
- TL&TPL (NCT07287865)
- Testing
- surgical flap
- Where
- Italy
- Volunteers
- 400 people
- Sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
Total Laryngectomy Patients Who Use Voice Prostheses
Mixed-species Biofilms and Silicone Device Longevity
The purpose of this study is to determine whether the mix of microbial species isolated from biofilm-clogged voice prostheses is specific to each participant, whether the microbes are orally-derived and whether the presence of…
- Trial name
- NCT02507401
- Where
- United Kingdom
- Volunteers
- 14 people
- Sponsor
- University of Aberdeen
Neck Cancer, Larynx
Bilateral Elective Neck Dissection in Salvage Total Laryngectomy
The aim of this study is to evaluate the role of elective bilateral neck dissection in patients with clinically negative lymph nodes (cN0) who underwent salvage total laryngectomy, by estimating the prevalence of histologically…
- Conditions
- Neck Cancer, Larynx, Larynx Cancer, Neck
- Trial name
- NCT05746780
- Testing
- Elective bilateral neck dissection in cN0 patients
- Where
- Italy
- Volunteers
- 80 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Total Laryngectomy
Short-term Clinical Feasibility of the New Provox Vega 22.5 Voice Prosthesis
The purpose of this study is to investigate the performance of a new voice prosthesis in comparison with the Provox2 and the Provox ActiValve voice prosthesis in 15 laryngectomized patients.
- Trial name
- NCT00743262
- Testing
- Provox voice prosthesis
- Where
- Netherlands
- Volunteers
- 15 people
- Sponsor
- Atos Medical AB
Quality of Life, Depressive Symptoms
The Effect of Art Therapy on Total Laryngectomy Patients
Total laryngectomy (TL) patients suffer from a myriad of psychological and physiological difficulties following surgery. One of their main difficulties in communication due to problems in speaking.
- Trial name
- NCT03503435
- Testing
- Group art therapy
- Sponsor
- University of Haifa
Cancer, Otorhinolaryngeal
Rehabilitation Improved by Early Detection of Fisyulas Post (Pharyngo) -Total Laryngectomy by Cytokine Measurement on Drainage Fluid on the Second Post-Operative Day
Post-pharyngo-laryngectomy fistula is a frequent surgical complication, resulting in delayed patient management and reduced quality of life.
- Trial name
- RADEFILAC (NCT06604494)
- Testing
- early feeding resumption, late feeding resumption
- Where
- 7 sites in France
- Volunteers
- 250 people
- Sponsor
- University Hospital, Clermont-Ferrand
Head and Neck Cancer
TPF Plus Radiotherapy and Cetuximab to Avoid Total Laryngectomy in Patients With Larynx Cancer
A Phase II Trial With Radiotherapy Plus Cetuximab to Evaluate Specific Survival Free of Laryngectomy in Patients With Resectable and Locally Advanced Larynx Cancer, After Treatment With TPF Chemotherapy.
- Trial name
- NCT00765011
- Testing
- TPF, radiotherapy and cetuximab, H&N surgery
- Where
- 17 sites in Spain
- Volunteers
- 94 people
- Sponsor
- Grupo Español de Tratamiento de Tumores de Cabeza y Cuello
Laryngeal Cancer, Hypopharynx Cancer
A Novel Modified Tracheo-Esophageal Voice Prosthesis for Total Laryngectomy Patients
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.
- Trial name
- TEP (NCT03039465)
- Testing
- Modified Trans-Esophageal Prosthesis
- Where
- India
- Volunteers
- 50 people
- Sponsor
- HealthCare Global Enterprise Ltd.
Laryngectomy; Status
Effect of Dexmedetomidine in Preventing Cough and Postoperative Pain After Laryngeal Surgery for Cancer
Background: During emergence from anesthesia for partial and total laryngectomy, severe airway reflex and systemic hypertension during recovery may lead to pneumoderm, hemorrhage, pneumomediastinum or pneumothorax.
- Trial name
- NCT03918889
- Testing
- Dexmedetomidine Injectable Product, Midazolam injection
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Eye & ENT Hospital of Fudan University
Total Laryngectomy
Long Term Use of the Provox Vega 22.5
The purpose of this study was to investigate the long-term feasibility of the new Provox Vega 22.5 voice prosthesis (outer diameter of 22.5 French) and its insertion system (SmartInserter) in laryngectomized patients who…
- Trial name
- NCT00884910
- Testing
- Provox Vega voice prosthesis 22.5 Fr
- Where
- Netherlands
- Volunteers
- 33 people
- Sponsor
- Atos Medical AB