Defining a Technique for the Use of Cryogenic Catheters for Biopsy and Ablation for the Diagnostic and Treatment of Pulmonary Lesions: An Ex-Vivo Human Lung Model Study.

ConditionLung Diseases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre hospitalier de l'Université de Montréal (CHUM)

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients undergoing lung transplant surgery

Disqualifiers

Organ donor ineligible to donate lungs

Healthy individuals

Trial design

Design model

Single group

Treatments tested in this trial

  • Cryo Ex Vivo

    Diagnostic test

    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.

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Ex Vivo CryoExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Measure of Pleural breakage (Absent or Present)

Develop a standardized methodology for the use of novel cryoprobes for transbronchial lung biopsies and ablation of pulmonary lesions

Time frame
48 months
2

Temperature of ice ball at center; Temperature of ice ball at periphery; Temperature of ice ball at varying distances from ice ball

Develop a standardized methodology for the use of novel cryoprobes for transbronchial lung biopsies and ablation of pulmonary lesions

Time frame
48 months
3

Model of cryogen

Develop a standardized methodology for the use of novel cryoprobes for transbronchial lung biopsies and ablation of pulmonary lesions

Time frame
48 months
4

Freezing Time

Develop a standardized methodology for the use of novel cryoprobes for transbronchial lung biopsies and ablation of pulmonary lesions

Time frame
48 months

Secondary outcomes

1

Blood loss and complication

Feasibility of transbronchial lung cryobiopsy and cryoablation

Time frame
48 months

Other outcomes

Sponsors and contacts

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