- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00396617
Voice Prosthesis Made in Porous Titanium After Total Laryngectomy or Pharyngolaryngectomy
June 28, 2012 updated by: University Hospital, Strasbourg, France
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
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
14
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Christian DEBRY, MD
- Phone Number: 33.3.88.12.76.44
- Email: christian.debry@chru-strasbourg.fr
Study Locations
-
-
-
Strasbourg, France, 67082
- Recruiting
- Service d'ORL et de Chirurgie Cervico-Faciale, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg
-
Contact:
- Christian DEBRY, MD
- Phone Number: 33.3.88.12.76.44
- Email: christian.debry@chru-strasbourg.fr
-
Sub-Investigator:
- Patrick HEMAR, MD
-
Sub-Investigator:
- Philippe SCHULTZ, MD
-
Principal Investigator:
- Christian DEBRY, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria:
- age more than 18
- total laryngectomy or pharyngo-larynctomy
Exclusion criteria:
- pregnant women-age less than 18
- major pulmonary bronchitis
- major neurological disorders
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Clinical measures concerning peri and intra prosthetic leakage
Time Frame: days 8,15,21,30 - months : 2 ,4,6,8, 10, 12, 15,18,21,24,30, 36
|
days 8,15,21,30 - months : 2 ,4,6,8, 10, 12, 15,18,21,24,30, 36
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Phonology's measures
Time Frame: months 1, 3,12
|
months 1, 3,12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Christian DEBRY, MD, Hôpitaux Universitaires de Strasbourg
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2007
Primary Completion (Anticipated)
September 1, 2013
Study Completion (Anticipated)
March 1, 2014
Study Registration Dates
First Submitted
November 6, 2006
First Submitted That Met QC Criteria
November 6, 2006
First Posted (Estimate)
November 7, 2006
Study Record Updates
Last Update Posted (Estimate)
July 2, 2012
Last Update Submitted That Met QC Criteria
June 28, 2012
Last Verified
June 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Respiratory Tract Neoplasms
- Otorhinolaryngologic Neoplasms
- Head and Neck Neoplasms
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Laryngeal Diseases
- Neoplasms
- Carcinoma
- Laryngeal Neoplasms
- Pharyngeal Neoplasms
Other Study ID Numbers
- 3736
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Carcinoma
-
Mayo ClinicNational Cancer Institute (NCI)Active, not recruitingEstrogen Receptor Positive | Ductal Breast Carcinoma In Situ | Grade 1 Invasive Breast Carcinoma | Grade 2 Invasive Breast Carcinoma | Grade 3 Invasive Breast Carcinoma | Invasive Ductal and Lobular Carcinoma In Situ | Mucinous Breast Carcinoma | Tubular Breast CarcinomaUnited States
-
Eye & ENT Hospital of Fudan UniversityChanghai Hospital; Fudan University; RenJi Hospital; Xinhua Hospital, Shanghai... and other collaboratorsRecruitingGlottic Carcinoma | Supraglottic Carcinoma | Subglottic Carcinoma | Pyriform Sinus Carcinoma | Postcricoid Carcinoma | Posterior Pharyngeal Wall CarcinomaChina
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)Active, not recruitingMetastatic Bladder Urothelial Carcinoma | Metastatic Renal Pelvis Urothelial Carcinoma | Metastatic Ureter Urothelial Carcinoma | Metastatic Urethral Urothelial Carcinoma | Metastatic Urothelial Carcinoma | Locally Advanced Bladder Urothelial Carcinoma | Locally Advanced Renal Pelvis Urothelial... and other conditionsUnited States
-
Mamta ParikhNational Cancer Institute (NCI); Karyopharm Therapeutics IncRecruitingMetastatic Urothelial Carcinoma | Locally Advanced Urothelial Carcinoma | Advanced Urothelial Carcinoma | Refractory Urothelial CarcinomaUnited States
-
National Cancer Institute (NCI)Not yet recruitingBreast Carcinoma | Breast Ductal Carcinoma In Situ | Breast Lobular Carcinoma In Situ | Estrogen Receptor-Positive Breast CarcinomaUnited States
-
Roswell Park Cancer InstituteIovance Biotherapeutics, Inc.WithdrawnMetastatic Bladder Urothelial Carcinoma | Metastatic Renal Pelvis Urothelial Carcinoma | Metastatic Ureter Urothelial Carcinoma | Metastatic Urethral Urothelial Carcinoma | Unresectable Renal Pelvis Urothelial Carcinoma | Unresectable Ureter Urothelial CarcinomaUnited States
-
National Cancer Institute (NCI)Active, not recruitingBreast Ductal Carcinoma In Situ | Invasive Breast Carcinoma | Multicentric Breast Carcinoma | Multifocal Breast Carcinoma | Synchronous Bilateral Breast CarcinomaUnited States, France, Spain, Canada, Saudi Arabia, Puerto Rico, Korea, Republic of, Ireland, Colombia, Mexico
-
National Cancer Institute (NCI)CompletedRecurrent Hypopharyngeal Squamous Cell Carcinoma | Recurrent Laryngeal Squamous Cell Carcinoma | Recurrent Oropharyngeal Squamous Cell Carcinoma | Recurrent Lip and Oral Cavity Squamous Cell Carcinoma | Recurrent Laryngeal Verrucous Carcinoma | Recurrent Oral Cavity Verrucous Carcinoma | Tongue... and other conditionsUnited States
-
Roswell Park Cancer InstituteNational Comprehensive Cancer NetworkCompletedAdvanced Adult Hepatocellular Carcinoma | Localized Non-Resectable Adult Hepatocellular Carcinoma | Stage IIIA Hepatocellular Carcinoma | Stage IIIB Hepatocellular Carcinoma | Stage IIIC Hepatocellular Carcinoma | Stage IVA Hepatocellular Carcinoma | Stage IVB Hepatocellular Carcinoma | Stage III... and other conditionsUnited States
-
Mayo ClinicRecruitingHead and Neck Carcinoma | Metastatic Malignant Neoplasm in the Lymph Nodes | Skin Carcinoma | Nasal Cavity Carcinoma | Oral Cavity Carcinoma | Paranasal Sinus Carcinoma | Salivary Gland Carcinoma | Hypopharyngeal Carcinoma | Laryngeal Carcinoma | Oropharyngeal Carcinoma | Head and Neck Carcinoma of Unknown...United States
Clinical Trials on prothesis voice
-
University Hospital, ToulouseRecruiting
-
Implants Diffusion InternationalRecruiting
-
Estas Tıbbi Mamülleri MedikalKlinar CRORecruitingPrimary and Secondary Bone Tumor in the Proximal Femur RegionTurkey
-
BBraun Medical SASRecruiting
-
BBraun Medical SASRecruiting
-
VisionCare, Inc.TerminatedAge Related Macular DegenerationIreland, Spain
-
Indiana UniversityCompleted
-
NGMedical GmbHRecruitingRadiculopathy | Stenoses, Spinal | Discopathy | Herniated Cervical DiscAustria, Germany
-
University of VirginiaUniversity of Colorado, DenverRecruiting
-
University of ArizonaMayo ClinicUnknownPresbylarynx | Age-Related DysphoniaUnited States