Recruiting

Cryogenic Catheters

Sponsor:

Centre hospitalier de l'Université de Montréal (CHUM)

Code:

NCT05948904

Conditions

Lung Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cryo Ex Vivo

Study Details

Brief summary:

Developing a standardized methodology for the use of novel cryogenic catheters for transbronchial cryobiopsy and cryoablation of pulmonary lesions.

Conditions

Lung Diseases

Study ID

NCT05948904

Start date

Nov 3, 2023

Status verified date

Mar, 2026

Completion date

Apr 1, 2027

Anticipated

Primary completion date

Apr 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients undergoing lung transplant surgery

Exclusion Criteria:

  • Organ donor ineligible to donate lungs
  • Healthy individuals

Study Design

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Ex Vivo Cryo

Multiple procedures will be performed to each model in order to accomplish the objectives of the study. Tissue samples will be taken from the models and images will be performed. This will allow us to determine which configuration is the optimal for obtaining the more effective and stable models that could offer the best quality specimens as well.

Interventions

Cryo Ex Vivo

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.

Primary outcome measure

  • Measure of Pleural breakage (Absent or Present) [ Time Frame: 48 months ]
  • Temperature of ice ball at center; Temperature of ice ball at periphery; Temperature of ice ball at varying distances from ice ball [ Time Frame: 48 months ]
  • Model of cryogen [ Time Frame: 48 months ]
  • Freezing Time [ Time Frame: 48 months ]
  • Size of resected specimen [ Time Frame: 48 months ]

Central Contacts and Locations

Central contacts

Moishe Liberman, MD

514-890-8000moishe.liberman@umontreal.ca

Adeline Jouquan, MSc

514-890-8000adeline.jouquan.chum@ssss.gouv.qc.ca

Locations

CHUM

Recruiting

Montreal, Quebec, Canada, H2X 0A9

Contacts

Moishe Liberman, MD

514-890-8000moishe.liberman@umontreal.ca

More Information

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Last update posted

Mar 18, 2026

Last verified

Mar, 2026

Keywords

  • Lung
  • cryobiopsy
  • cryoablation
  • transbronchial intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre hospitalier de l'Université de Montréal (CHUM) on 2026-03-18.