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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00396617
Other study ID # 3736
Secondary ID
Status Recruiting
Phase Phase 1
First received November 6, 2006
Last updated June 28, 2012
Start date December 2007
Est. completion date March 2014

Study information

Verified date June 2012
Source University Hospital, Strasbourg, France
Contact Christian DEBRY, MD
Phone 33.3.88.12.76.44
Email christian.debry@chru-strasbourg.fr
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Recruiting
Enrollment 14
Est. completion date March 2014
Est. primary completion date September 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Device:
prothesis voice
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.
Procedure:
total laryngectomy
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.

Locations

Country Name City State
France Service d'ORL et de Chirurgie Cervico-Faciale, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg Strasbourg

Sponsors (3)

Lead Sponsor Collaborator
University Hospital, Strasbourg, France OseoAnvar, Réseau National des Technologies de Santé

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical measures concerning peri and intra prosthetic leakage days 8,15,21,30 - months : 2 ,4,6,8, 10, 12, 15,18,21,24,30, 36 No
Secondary Phonology's measures months 1, 3,12 No
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