Implantation of Porous Titanium Prosthesis in Laryngeal Surgery

University Hospital, Strasbourg, France

Status and phase: Unknown; Phase 2

Conditions: Vocal Cord Paralysis

Treatments: Device: Vocal fold medialization (thyroplasty) prosthesis by insertion of a new implant allowing very easy and quick setting

Study type: Interventional

Funder types: Other

Identifiers

NCT00213863

3097

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males or females greater than 18 years old

Exclusion criteria

• Age less than 18 years
• Pregnant women
• Local carcinoma excluding radiotherapeutic or surgical control
• Bad general condition
• Contraindication to general anesthesia
• Non-controlled diabetes

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)