Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study evaluates a medialization implant to treat vocal cord paralysis, to permit it to adjust the quality of the voice under local or general anesthesia. The aim is to restore phonation using a porous titanium prosthesis in laryngeal surgery.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vocal fold medialization (thyroplasty) prosthesis by insertion of a new implant allowing very easy and quick setting | Device | The porous titanium prosthesis is implanted under local anaesthesia. Neck incision is performed in order to expose the thyroidal cartilage. A window is then opened in this cartilage, and the implant is placed in contact with the vocal muscles. The patient is then asked to speak in order to achieve the implant best setting. |
| Measure | Description | Time Frame |
|---|---|---|
| Nasofibroscopy | 8 days and 3 months after surgery | |
| Voice control and recording | 8, 15, 30 days, 3, 6 months after surgery and then, every 6 months during the whole trial | |
| All types of complication | 8, 15, 30 days, 3, 6 months after surgery and then, every 6 months during the whole trial |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christian Debry, MD | Contact | christian.debry@chru-strasbourg.fr |
| Name | Affiliation | Role |
|---|---|---|
| Christian Debry, MD | Hopitaux Universitaires de Strasbourg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service d'Oto-Rhino-Laryngologie et de Chirurgie Cervico-Faciale, Hôpital de Hautepierre | Recruiting | Strasbourg | France |
Not provided
| ID | Term |
|---|---|
| D014826 | Vocal Cord Paralysis |
| ID | Term |
|---|---|
| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D020421 | Vagus Nerve Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D058753 | Laryngoplasty |
| ID | Term |
|---|---|
| D013517 | Otorhinolaryngologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |