Infections

All Conditions

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

Tuberculosis

Lung Neoplasms

Constriction, Pathologic

Tracheitis

Tracheal Stenosis

Tracheal Diseases

Communicable Diseases

Mycobacterium Infections

Bacterial Infections

Gram-Positive Bacterial Infections

Mycoses

Bacterial Infections and Mycoses

Respiratory Tract Diseases

Respiratory Tract Infections

After resection of a segment of tracheal or bronchial lesion, reconstruct the airway with cryopreserved aortic allograft.

After resection of the tracheal or bronchial lesion with standard surgical techniques, the airway gap is reconstructed with a segment of human cryopreserved (-80 celsius degree) aortic allograft, which was not matched by the ABO and leukocyte antigen systems. The anastomosis is performed with standard technique for airway anastomosis. An Ultraflex covered tracheobronchial stent is inserted to prevent collapse for the aortic graft.

Cryopreserved aorta

Jin-Shing Chen, MD, PhD

We used a segment of cryopreserved aorta as a graft for reconstruction for long segment tracheobronchial lesion in human.

Feasibility of Tracheobronchial Reconstruction Using Bioengineered Aortic Matrices

The occurrence of complication including 1) anastomotic leakage, 2) pneumonia, 3) difficult weaning, 4) airway obstruction by granulation tissue, 5) stenosis.

National Taiwan University Hospital

Digestive System Diseases

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Esophageal Neoplasms

Sarcoidosis

Barrett Esophagus

Bronchial Neoplasms

Esophageal Stenosis

Pathological Conditions, Anatomical

Precancerous Conditions

Esophageal Diseases

Gastrointestinal Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Bronchial Diseases

Esophageal Cancer

truFreeze Spray Cryotherapy administered as routine clinical care

truFreeze Spray Cryotherapy

Nicholas Shaheen, MD

Robert F Browning, MD

To collect efficacy and outcomes data related to the use of trūFreeze® spray cryotherapy for the treatment of unwanted tissue in the pulmonary and gastrointestinal settings.

This is a prospective, multi-center registry of patients who are currently undergoing spray cryotherapy using the trūFreeze® device. The registry population consists of patients who are being treated using the spray cryotherapy trūFreeze® device for the removal of unwanted tissue, such as malignant or pre-malignant conditions in the pulmonary or gastrointestinal settings.

Patients eligible to participate in the registry will have disease and treatment specific data collected throughout therapy and long-term follow-up. Subjects will be considered to have completed the registry when data from the 5 year follow-up visit has been collected. The beginning of the follow-up period commences with the first endoscopic treatment session.

Subjects may be withdrawn prior to this for any of the following reasons:

1. Death, or
2. Lost to Follow-Up, or
3. Withdrawal of consent, or
4. Discontinuation by the investigator. Three attempts at contact using two different methods are required prior to determination that the subject is lost to follow-up. Attempts at contact must be with certified letters OR documented telephone contact.

The registry will utilize electronic case report forms using a web-based platform housed at the University of North Carolina at Chapel Hill. Access to the database will be limited to individuals involved in the research registry and will require a unique user ID and password. All access to the database and web-based application will be encrypted (HTTPS) and electronic systems compliant with applicable privacy and security regulations. To maintain patient confidentiality, all subjects will be assigned a registry identification number, and this will be the only link between subject identity and treatment information. Read-only access will be provided to any personnel who is not an administrator or responsible for data entry.

All data requested on the case report form must be recorded. All missing data must be explained. The system allows sites to directly enter data electronically, however sites are still responsible for ensuring they have source documents that support all data entered electronically that are separate and verifiable. The registry system will maintain an audit trail that captures when electronic entries are changed, what the change was, and who made the change.

The investigators will ensure the capability for inspections of applicable registry-related facilities (e.g. pharmacy, diagnostic laboratory, etc.). The registry will be monitored by the sponsor, and allow auditing by the Institutional Review Board, government regulatory bodies, and University compliance and quality assurance groups of all registry related documents (e.g. source documents, regulatory documents, data collection instruments, registry data, etc.).

trūFreeze® Spray Cryotherapy Patient Registry

The registry population consists of patients who are being treated using the trūFreeze® spray cryotherapy device for the removal of unwanted tissue, such as malignant or pre-malignant conditions in the pulmonary or gastrointestinal settings.

All adverse events occurring during the registry period must be recorded. The clinical course of each event should be followed until resolution, stabilization, or until it has been determined that the registry treatment or participation is not the cause. Serious adverse events that are still ongoing at the end of the Spray Cryotherapy Patient Registry registry period must be followed up to determine the final outcome. Any serious adverse event that occurs after the registry period and is considered to be possibly related to the trūFreeze® spray cryotherapy device or registry participation should be recorded and reported immediately.

US Endoscopy Group Inc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Feasibility of Tracheobronchial Reconstruction Using Bioengineered Aortic Matrices	NCT04850742	Trachea Disease... Tracheal Stenos... Lung Cancer Tuberculosis; T... Airway Disease	Cryopreserved a...	20 Years -	National Taiwan University Hospital
Feasibility of Tracheobronchial Reconstruction Using Bioengineered Aortic Matrices	NCT04850742	Trachea Disease... Tracheal Stenos... Lung Cancer Tuberculosis; T... Airway Disease	Cryopreserved a...	20 Years -	National Taiwan University Hospital
trūFreeze® Spray Cryotherapy Patient Registry	NCT01802203	Barrett Esophag... Esophageal Dysp... Esophageal Neop... Esophageal Sten... Bronchial Neopl... Stenosis of Bro...	truFreeze Spray...	18 Years -	US Endoscopy Group Inc.

Spots Global Cancer Trial Database for tracheal stenosis