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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
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.
Mayo Clinic in Arizona
Phoenix, Arizona, United States
Survival of the allograft at the one-year visit.
Survival of the allograft as indicated by histological rejection grading.
Time frame: 1 year
Swallowing without aspiration at the one-year visit.
Time frame: 1 year
Voice Evaluation
Standard voice evaluation will include voice recordings, acoustic and aerodynamic measurements as compared to baseline measurements.
Time frame: 1 year
Pulmonary function
Pulmonary function values within normal range.
Time frame: 1 year
Ability to have tracheotomy tube decannulated
Ability to have tracheotomy tube decannulated after successful capping trials.
Time frame: 1 year
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