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Air Leak Management for Pneumothorax (CT0128 Trial)

N/A

Recruiting

Led By Moishe Liberman, MD

Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 months

Awards & highlights

CT0128 Trial Summary

This trial tests a method to detect, reduce and treat air leaks during surgery, potentially reducing complications, morbidity and hospital stays for lung surgery.

Who is the study for?

This trial is for patients undergoing lung transplant surgery who cannot donate their lungs. It's not open to healthy individuals.Check my eligibility

What is being tested?

The study aims to develop a method to detect, measure, and treat air leaks during surgery using a bio-adhesive. This could reduce complications and hospital stays after lung surgeries.See study design

What are the potential side effects?

Potential side effects may include reactions to the bio-adhesive such as inflammation or infection at the application site, but specific side effects will depend on individual patient responses.

CT0128 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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.

Secondary outcome measures

Establishing a standardized measure to localize air leaks in a physiological setting.

Quantify and treat air leaks in a physiological setting

CT0128 Trial Design

1Treatment groups

Experimental Treatment

Group I: Air LeaksExperimental Treatment1 Intervention

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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor

366 Previous Clinical Trials

129,437 Total Patients Enrolled

Moishe Liberman, MDPrincipal InvestigatorCHUM

3 Previous Clinical Trials

365 Total Patients Enrolled

Media Library

Air Leaks Clinical Trial Eligibility Overview. Trial Name: NCT05854654 — N/A

Pneumothorax Research Study Groups: Air Leaks

Pneumothorax Clinical Trial 2023: Air Leaks Highlights & Side Effects. Trial Name: NCT05854654 — N/A

Air Leaks 2023 Treatment Timeline for Medical Study. Trial Name: NCT05854654 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment for this investigative procedure currently underway?

"Clinicaltrials.gov informs us that this particular trial is not presently enrolling participants, having first been posted on the 30th of May in 2023 and last updated on 2nd of the same month. Nevertheless, there are 1 other studies currently recruiting patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Air Leak Detection and Treatment

2023. "Air Leak Detection and Treatment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05854654.