Clinical trials: Laryngectomy
Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent/Metastatic (R/M), Locally Advanced Laryngeal Squamous Cell Carcinoma
Window of Opportunity in Preserving Laryngeal Function Trial
This trial will study the safety and tolerability and disease survival rates in adult patients with recurrent/metastatic (R/M) HNSCC when treated with carboplatin or cisplatin, paclitaxel, and toripalimab.
- Conditions
- Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent/Metastatic (R/M), Locally Advanced Laryngeal Squamous Cell Carcinoma, Hypopharyngeal Squamous Cell Carcinoma
- Trial name
- WOLF (NCT07423078)
- Testing
- Toripalimab, Carboplatin, Cisplatin
- Where
- United States
- Volunteers
- 87 people
- Sponsor
- Matthew Spector
Laryngectomy, Voice
Estimation of Benefit From Regular Versus Leakage-related Exchange of Voice Prosthesis in Patients Post Laryngectomy.
The tracheoesophageal voice with voice prosthesis is currently the mainstay of voice rehabilitation post laryngectomy. The primary surgical technique of tracheoesophageal fistula formation with insertion of prosthesis and quick…
- Conditions
- Laryngectomy, Voice, Prosthesis Failure
- Trial name
- RvLPE (NCT04268459)
- Testing
- Provox prosthesis exchange
- Where
- Poland
- Volunteers
- 70 people
- Sponsor
- Medical University of Warsaw
Laryngeal Cancer
Comparison of 2 Cefazolin Prophylactic Protocol in Laryngectomy Patients
Patients who need major head \& neck surgery are at risk of post operative wound infection. In spite of role of antibiotics in prophylaxis of clean contaminated head and neck surgery has been well documented, controversy exists…
- Trial name
- NCT00467948
- Testing
- cefazolin
- Where
- Iran
- Volunteers
- 90 people
- Sponsor
- Tehran University of Medical Sciences
Pharyngeal Neoplasms, Laryngeal Neoplasms
Voice Prosthesis Made in Porous Titanium After Total Laryngectomy or Pharyngolaryngectomy
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.
- Conditions
- Pharyngeal Neoplasms, Laryngeal Neoplasms, Carcinoma
- Trial name
- NCT00396617
- Testing
- prothesis voice, total laryngectomy
- Where
- France
- Volunteers
- 14 people
- Sponsor
- University Hospital, Strasbourg, France
Laryngectomy; Status
Quality of Life in Patients After Pharyngolaryngectomy
Laryngeal cancer is an indication for a laryngectomy (separation of the airways and digestive tract). Laryngectomy causes a permanent disruption of self-perception.
- Trial name
- LARYNG-QDV (NCT05157555)
- Testing
- Data collection
- Where
- France
- Volunteers
- 60 people
- Sponsor
- Université de Reims Champagne-Ardenne
Laryngectomy; Status
Evaluation of the Safety and Efficacy of Voice Prosthesis in Voice Reconstruction After Total Laryngectomy
The objective of the study is to evaluate the clinical safety and efficacy of voice prosthesis for voice reconstruction after total laryngectomy in China.
- Trial name
- NCT05482815
- Testing
- Provox Vega Voice prosthesis
- Where
- 3 sites in China
- Volunteers
- 80 people
- Sponsor
- Atos Medical AB
Laryngectomy
Day/Night Regimen With Provox Life Heat and Moisture Exchangers
Purpose and Aim: This research is about patients who have had a total laryngectomy, trialing a new range of Heat and Moisture Exchangers (HMEs) - referred to as the "Provox Life™ range of HMEs".
- Trial name
- NCT04943731
- Testing
- Provox Life
- Where
- 3 sites in Australia
- Volunteers
- 48 people
- Sponsor
- Atos Medical AB
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
Speech Disorders, Speech Dysfunction
Gender Disparities in Voice Outcomes After Tracheoesophageal Puncture in Total Laryngectomy Patients (UC Davis)
To perform a multi-site prospective study assessing, both subjectively and objectively, the gender disparities in speech outcomes of patients using TEP after total laryngectomy.
- Conditions
- Speech Disorders, Speech Dysfunction, Laryngectomy; Status, Tracheoesophageal Prosthesis
- Trial name
- NCT05489965
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- University of California, Davis
Surgery Site Fistula
Hypopharynx ICG to Reduce the Fistula Rate in Patients Undergoing Salvage Laryngectomy
A laryngectomy involves removing the voice box from the throat. After the voice box has been removed from the throat, the surgeon sews the throat closed.
- Trial name
- NCT05350540
- Testing
- ICG dye
- Where
- Canada
- Volunteers
- 70 people
- Sponsor
- University Health Network, Toronto
Cancer of the Larynx
Speech and Swallowing Characteristics of Patients After Laryngectomy and the Effect on Quality of Life
Swallowing and speech difficulties will be observed in patients post laryngectomy. These difficulties will cause decreased in quality of life.
- Trial name
- NCT01607138
- Volunteers
- 40 people
- Sponsor
- Tel-Aviv Sourasky Medical Center
Squamous Cell Carcinoma of Head and Neck, Hypopharyngeal Squamous Cell Carcinoma
European Larynx Organ Preservation Study (ELOS) [MK-3475-C44]
ELOS is a prospective, randomized, open-label, controlled, two-armed parallel group, phase II multicentre trial in local advanced stage III, IVA/B head and neck squamous cell carcinoma of the larynx or hypopharynx (LHNSCC) with…
- Conditions
- Squamous Cell Carcinoma of Head and Neck, Hypopharyngeal Squamous Cell Carcinoma, Laryngeal Squamous Cell Carcinoma Stage III, Laryngeal Squamous Cell Carcinoma Stage IV
- Trial name
- ELOS (NCT06137378)
- Testing
- KEYTRUDA®
- Where
- 9 sites in Germany
- Volunteers
- 140 people
- Sponsor
- University of Leipzig
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 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
Laryngectomy
Post-operative Use of New Adhesive After Total Laryngectomy
The goal of this clinical trial is to evaluate the feasibility, safety, and performance of the new adhesive when used in the immediate post-operative period after total laryngectomy.
- Trial name
- NCT07366281
- Testing
- Provox Life Comfort Adhesive
- Where
- 3 sites in Netherlands
- Volunteers
- 25 people
- Sponsor
- Atos Medical AB
Laryngectomy
A Randomized Trial Comparing Routine Use of the ActiValve to Standard Voice Prostheses
The goal of this clinical research study is to learn if regular use of Provox® ActiValve® by patients after a total laryngectomy with TEP can decrease the number of VP device replacements needed annually.
- Trial name
- NCT07369050
- Testing
- Provox® ActiValve®
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- M.D. Anderson Cancer Center
Laryngeal Neoplasm
The Efficacy of Superficial Cervical Block Application in Postoperative Analgesia Management in Patients Undergoing Total Laryngectomy and Bilateral Neck Dissection
The goal of this clinical trial is to evaluate the efficacy of the superficial cervical block in postoperative pain management for patients undergoing total laryngectomy and bilateral neck dissection.
- Trial name
- NCT06852651
- Testing
- Superficial Cervical Block (SCB) Group
- Where
- Turkey (Türkiye)
- Volunteers
- 50 people
- Sponsor
- Başakşehir Çam & Sakura City Hospital
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
Larynx Carcinoma
The Role of the Free/Pedunculated Flap in Total Laryngectomy After (Chemo-)Radiotherapy Failure for Laryngeal Carcinoma: Impact on the Risk of Pharyngocutaneous Fistula (PCF)
Multicenter, prospective, randomized study aimed at evaluating the difference in risk of PCF after salvage laryngectomy in two groups of patients: one cohort treated with Total Laryngectomy (LT) with primary suture, a second…
- Trial name
- NCT06287034
- Testing
- Primary suture
- Where
- Italy
- Volunteers
- 102 people
- Sponsor
- Regina Elena Cancer Institute
Supraglottic Squamous Cell Carcinoma
Local Control After Robot-assisted Supraglottic Laryngectomy
Transoral robotic surgery is an option to treat supraglottic squamous cell carcinomas. Oncological outcomes 2 years after transoral robotic surgery for supraglottic laryngectomy were studied.
- Trial name
- NCT03357107
- Testing
- Transoral robotic surgery (TORS)
- Where
- France
- Volunteers
- 122 people
- Sponsor
- Hospices Civils de Lyon