Join
today

Boliven PRO is more than just Clinical Trials

  • Search for throughout all clinical trials
  • Analyze data with charts and graphs, then download your results
  • Share lists of patents with your clients

Search trademarks, companies, patents & more!

Voice Prosthesis Made in Porous Titanium After Total Laryngectomy or Pharyngolaryngectomy


Trial Overview

StatusConditionSponsor/Collaborator(s)First ReceivedLast ChangedVerification Date
Recruiting Pharyngeal Neoplasms; Laryngeal Neoplasms; Carcinoma University Hospital, Strasbourg, France Other
collaborator(s): OseoAnvar; Réseau National des Technologies de Santé
November 6, 2006 June 28, 2012 June 2012

Study TypeStudy DesignPhaseEnrollmentStart DateEnd Date
Interventional Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment Phase 1 14 December 2007 -

Locations

FacilityAddressContactPhoneEmailStatus
Service d'ORL et de Chirurgie Cervico-Faciale, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg Strasbourg 67082 France Christian DEBRY, MD - christian.debry@chru-strasbourg.fr Recruiting

Intervention

TypeInterventionDescription
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.

Outcome

TypeMeasureTime FrameSafety 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

Official Title

Voice Prosthesis Made in Porous Titanium After Total Laryngectomy or Pharyngolaryngectomy

Eligibility

GenderMinimum AgeMaximum AgeHealthy Volunteers
Both - N/A No

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