NCT03269396

Laryngeal Allograft Transplantation

A Prospective Nonrandomized Study of Laryngeal Allograft Transplantation Clinical Investigation

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this proposed study is to obtain safety and efficacy data on human laryngeal allograft transplantation in an effort to safely use these procedures as a viable reconstructive option for patients with severe laryngeal or laryngotracheal incompetence.

Detailed description

Patients with severe laryngeal or laryngotracheal incompetence without other reconstructive options will be considered for cadaveric laryngotracheal transplantation. Data will be collected from 10 patients and will include length of hospital stay, short-term complications, long-term complications, hospital readmission, return trips to the operating room (OR), rejection episodes and severity, swallowing function, ability to have tracheotomy tube decannulated, voice parameters, pulmonary function, development of anti-donor antibodies, and quality of life scores.

Conditions

• Larynx Stenosis
• Larynx Disease
• Laryngectomy
• Larynx
• Larynx Fracture

Interventions

Type	Name	Description
PROCEDURE	Larynx Allograft Transplantation	This study is a prospective clinical trial designed to assess the efficacy and safety of laryngeal transplantation. A total of 10 patients will be enrolled over a five-year timeframe. Study length is 5 years.

Timeline

• Start date: 2023-05-19
• Primary completion: 2028-05-01
• Completion: 2033-05-01
• First posted: 2017-08-31
• Last updated: 2025-09-05

Locations

1 site across 1 country: United States