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Trial Title:
Voice Prosthesis Made in Porous Titanium After Total Laryngectomy or Pharyngolaryngectomy
NCT ID:
NCT00396617
Condition:
Pharyngeal Neoplasms
Laryngeal Neoplasms
Carcinoma
Conditions: Official terms:
Carcinoma
Neoplasms
Laryngeal Neoplasms
Pharyngeal Neoplasms
Conditions: Keywords:
Laryngeal or pharyngo-laryngeal's carcinoma,
voice prosthesis tracheooesophageal shunt,
titanium beads,
cellular colonization
Laryngeal or pharyngo-laryngeal's carcinoma
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Unknown status
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
prothesis voice
Description:
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.
Intervention type:
Procedure
Intervention name:
total laryngectomy
Description:
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.
Summary:
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
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Service d'ORL et de Chirurgie Cervico-Faciale, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg
Address:
City:
Strasbourg
Zip:
67082
Country:
France
Status:
Recruiting
Contact:
Last name:
Christian DEBRY, MD
Phone:
33.3.88.12.76.44
Email:
christian.debry@chru-strasbourg.fr
Investigator:
Last name:
Patrick HEMAR, MD
Email:
Sub-Investigator
Investigator:
Last name:
Philippe SCHULTZ, MD
Email:
Sub-Investigator
Investigator:
Last name:
Christian DEBRY, MD
Email:
Principal Investigator
Start date:
December 2007
Completion date:
March 2014
Lead sponsor:
Agency:
University Hospital, Strasbourg, France
Agency class:
Other
Collaborator:
Agency:
OseoAnvar
Agency class:
Other
Collaborator:
Agency:
Réseau National des Technologies de Santé
Agency class:
Other
Source:
University Hospital, Strasbourg, France
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00396617
