Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05854654

Defining Novel Strategies for the Diagnosis and Treatment of Intraoperative Air Leaks Using an Ex-Vivo Human Lung Model

Led by Centre hospitalier de l'Université de Montréal (CHUM) · Updated on 2026-03-18

200

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying ways to detect, measure, and treat air leaks that happen during lung surgery. The goal is to reduce complications, problems after surgery, and hospital stays for patients who have lung tissue removed. This research uses human lungs removed during transplant surgeries to create a stable and effective lung model for testing these methods. The lungs from transplant patients will be kept in a special acrylic box at 37 degrees Celsius and mechanically ventilated through an inserted tube to simulate breathing. Different procedures will be performed, including creating air leaks by stapling or cutting the lung tissue. A novel bio-adhesive sealant will be applied to these leaks to test its ability to seal them. The seal will be checked using gas and water techniques, and air leaks will be measured using an automated drainage system. Participants will not be directly involved since the study uses removed lungs. Researchers will perform multiple procedures on the lungs, collect tissue samples, and take images to find the best model settings. Lung tissue temperature, blood vessel pressure, and other factors will be monitored. The main outcomes measured are detecting and localizing air leaks and reducing their size by 80% with the bio sealant. The study follows a 48-month timeline for these assessments, with all lung specimens processed according to transplant protocols after testing.

CONDITIONS

Brief Title

Air Leak Detection and Treatment

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients undergoing lung transplant surgery
  • Organ donor ineligible to donate lungs
Not Eligible

You will not qualify if you...

  • Healthy individuals

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to several hours during ex-vivo lung testing

Participants' lungs obtained after transplantation surgery are prepared and mechanically ventilated in an ex-vivo model for diagnostic testing including endoscopic and RAB procedures.

1 visit (ex-vivo lung model testing session)

Long-term Monitoring

Duration - Up to 48 months

The lungs undergo repeated air leak testing and ventilation to assess the stability and effectiveness of the novel bio sealant over time.

No participant visits; monitoring occurs during the study period

Trial Site Locations

Total: 1 location

1

CHUM

Montreal, Quebec, Canada, H2X 0A9

Actively Recruiting

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Research Team

M

Moishe Liberman, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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