A Study to Optimize Patient Selection and Outcomes in Laryngeal Vascular Composite Allograft Transplantation

Overview

About this study

In-depth qualitative interviews will be performed to explore beliefs of laryngotracheal transplant candidates, their caregivers, and clinicians about their perceptions and experience of the laryngotracheal transplantation process. In addition, we will explore the quality of life of patients with a laryngectomy.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

Ages 18 years and older.
Male or female.
One of the following:
- Severe laryngeal dysfunction;
- Laryngeal stenosis;
- 5 years or longer s/p definitive management for head and neck cancer;
- Laryngeal cancer requiring total laryngectomy in a patient already on immunosuppression;
- Low-grade chondrosarcoma requiring total laryngectomy.
Ability to obtain informed consent from the patient.

Exclusion Criteria:

Poor surgical candidacy secondary to poor physical/mental health as determined by a pre-operative medical evaluation.
Less than 5 years s/p definitive management for cancer.
Uncontrolled diabetes mellitus. Once HbA1C < 7, reevaluate for candidacy.
Active smoking within 6 months.
Active alcoholism within 6 months.
Active substance use within 6 months.
Pregnancy.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Scottsdale/Phoenix, Ariz. Mayo Clinic principal investigator David Lott, M.D.	Closed-enrolling by invitation What is this? (?) "Close" Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.	Contact information: Stephanie Cotton Ph.D. (480) 301-4074 Zacharias.Stephanie@mayo.edu

Mayo Clinic Location

Status

Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

David Lott, M.D.

Closed-enrolling by invitation

Contact information:

Stephanie Cotton Ph.D.

(480) 301-4074

Zacharias.Stephanie@mayo.edu

More information

Publications

Publications are currently not available

Clinical Trials