Implantation of Porous Titanium Prosthesis in Laryngeal Surgery

• Sponsor: University Hospital, Strasbourg, France (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00213863
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Duration (Months): 71
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Vocal Cord Paralysis	Device: Vocal fold medialization (thyroplasty) prosthesis by insertion of a new implant allowing very easy and quick setting	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Implantation of Porous Titanium Prosthesis in Laryngeal Surgery
• Study Start Date: Dec 1, 2010
• Anticipated Primary Completion Date: May 1, 2016
• Anticipated Study Completion Date: Nov 1, 2016

Outcome Measures

Primary Outcome Measures

1. Nasofibroscopy [8 days and 3 months after surgery]

2. Voice control and recording [8, 15, 30 days, 3, 6 months after surgery and then, every 6 months during the whole trial]

3. All types of complication [8, 15, 30 days, 3, 6 months after surgery and then, every 6 months during the whole trial]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Service d'Oto-Rhino-Laryngologie et de Chirurgie Cervico-Faciale, Hôpital de Hautepierre	Strasbourg		France

Sponsors and Collaborators

• University Hospital, Strasbourg, France

Investigators

• Principal Investigator: Christian Debry, MD, Hopitaux Universitaires de Strasbourg

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Strasbourg, France
• ClinicalTrials.gov Identifier: NCT00213863
• Other Study ID Numbers: 3097
• First Posted: Sep 21, 2005
• Last Update Posted: Jul 2, 2012
• Last Verified: Jun 1, 2012

• Keywords provided by University Hospital, Strasbourg, France: porous titanium implants; thyroplasty; vocal cord paralysis; male or female more than 18 years old
• Additional relevant MeSH terms: Vocal Cord Paralysis; Paralysis

Study Results

No Results Posted as of Jul 2, 2012