Recruiting

Bio-Adhesive

Sponsor:

Centre hospitalier de l'Université de Montréal (CHUM)

Code:

NCT05854654

Conditions

Air Leak From Lung

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Air Leaks

Study Details

Brief summary:

Developing a methodology to detect, quantify and treat air leaks intraoperatively using a bio-adhesive, to thereby reduce postoperative surgical complications, morbidity, and length of stay for patients undergoing pulmonary resection.

Conditions

Air Leak From Lung

Study ID

NCT05854654

Start date

May 2, 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
  • Organ donor ineligible to donate lungs

Exclusion Criteria:

  • Healthy individuals

Study Design

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Air Leaks

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. In order to reproduce intraoperative air leaks, various manipulations, including stapling and creating lacerations of different depts and lengths on the parenchyma, will be performed on deflated lungs. Following the introduction of a leak, condensed gas will be pushed through the airway to precisely localize the defect. The sealant prepared at room temperature will then be applied in a thin layer to cover the defect and will be left to dry for 5 minutes. The seal will be tested using the condensed gas with the lung still deflated as well as with the water immersion technique after inflating the lung.

Interventions

Air Leaks

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 an hermetic closure proximal to the balloon.

This setting will allow us to perform several different endoscopic and RAB procedures in emulated physiologic conditions to complete the study.

Primary outcome measure

  • Detection and localisation of air leaks in deflated lungs using condensed air through the airway. Changing the size (ml) of air leaks by 80% by the use of a novel bio sealant directly on the lung parenchyma. [ Time Frame: 48 months ]

Central Contacts and Locations

Central contacts

Moishe Liberman, MD

514-890-8000moishe.liberman@umontreal.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

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.