CHUM
Montreal, Quebec, H2X 0A9, Canada
Location status: Recruiting
NCT Number: NCT05948904
Developing a standardized methodology for the use of novel cryogenic catheters for transbronchial cryobiopsy and cryoablation of pulmonary lesions.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Montreal, Quebec, H2X 0A9, Canada
Location status: Recruiting
Surgical lung biopsy (SLB) and surgical resection are the current gold standard for both tissue sampling and ablation of pulmonary lesions. Albeit the use of minimally invasive surgical techniques (VATS), these interventions are frequently associated with complications which include: prolonged air leak, pneumonia, prolonged length of stay in the intensive care unit as well as an increased mortality rate which is influenced by the nature (elective vs non-elective) of the case. To reduce trauma to patients, transbronchial interventions are becoming increasingly popular. However, current techniques have only been demonstrated in humans for lung biopsy and often provide lesser quality specimens than SLB. Promising results have been achieved using cryotechnology but a standardized technique has yet to be established.
To demonstrate the potential for transbronchial interventions using cryo, we aim to develop a standardized technique for transbronchial cryobiopsy and cryoablation of pulmonary lesions using a human ex-vivo model.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Lungs from patients undergoing lung transplantation after their removal from the recipient patient with previous informed consent signed before transplantation will be obtained. The organs will be placed in an acrylic box and will be kept at a temperature of 37 Celsius degrees. The lungs will be mechanically ventilated connected by an endotracheal tube size 8 inserted in the bronchus with the balloon inflated and a silk suture providing a hermetic closure proximal to the balloon.
Tissue samples will be taken from the models and images will be performed.
Time frame: 48 months
Develop a standardized methodology for the use of novel cryoprobes for transbronchial lung biopsies and ablation of pulmonary lesions
Time frame: 48 months
Develop a standardized methodology for the use of novel cryoprobes for transbronchial lung biopsies and ablation of pulmonary lesions
Time frame: 48 months
Develop a standardized methodology for the use of novel cryoprobes for transbronchial lung biopsies and ablation of pulmonary lesions
Time frame: 48 months
Develop a standardized methodology for the use of novel cryoprobes for transbronchial lung biopsies and ablation of pulmonary lesions
Time frame: 48 months
Develop a standardized methodology for the use of novel cryoprobes for transbronchial lung biopsies and ablation of pulmonary lesions
Time frame: 48 months
Feasibility of transbronchial lung cryobiopsy and cryoablation
Contact information is provided by the study sponsor or research team.
Adeline Jouquan, MSc
CONTACT
514-890-8000 ext. 26241
Moishe Liberman, MD
CONTACT
514-890-8000 ext. 26832
Centre hospitalier de l'Université de Montréal (CHUM)
Other
Acronym: CT0129
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06177717
Lung Diseases, Respiratory Tract Diseases
Birmingham, Alabama, United States
View Trial DetailsNCT06925373
Chronic Disease, Disease Attributes
Birmingham, Alabama, United States
View Trial DetailsNCT05922761
Bronchial Diseases, Bronchiolitis
Stanford, California, United States
View Trial DetailsNCT07227376
Lung Diseases, Pathological Conditions, Signs and Symptoms
Jacksonville, Florida, United States
View Trial Details