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Aerosol Glycerine System for Detecting Lung Air Leaks (CT0136 Trial)

N/A

Recruiting

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

CT0136 Trial Summary

This trial aims to develop a system to find air leaks in lungs after surgery, reducing postop complications, morbidity & length of stay.

Who is the study for?

This trial is for patients undergoing lung transplant surgery or those who are organ donors but ineligible to donate their lungs. Healthy individuals cannot participate.Check my eligibility

What is being tested?

The study is testing a new system that uses aerosol glycerine smoke to detect and localize air leaks during lung surgery, which could improve postoperative outcomes and reduce hospital stays.See study design

What are the potential side effects?

Potential side effects may include irritation from the glycerine smoke or reactions related to its inhalation, although specific side effects will be monitored throughout the trial.

CT0136 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

Localization efficacy

Secondary outcome measures

Duration of localization

Minimal leak localizable

Staple lines airtightness

Side effects data

From 2015 Phase 4 trial • 80 Patients • NCT02117687

Eye Irritation

Eye Pruritus

100%

80%

60%

40%

20%

Study treatment Arm

OPTIVE FUSION™

VISMED® Multi

CT0136 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. To establish a standard protocol to use our system we will use a dark box to validate that our system is able to localize the air leaks and to establish the best way to use the system. A one centimeter leak will be created on the lung with a scalpel. A laparoscope will be introduced via a trocar in the dark box and the surgeon will be asked to localize the leaks. The detection will be recorded via the laparoscope. The goal will be to perform a standardized protocol to use the system smoothly and efficiently on ex-vivo human lungs.

Do I qualify?Apply below to find out

Find a Location

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

Media Library

Air Leaks Clinical Trial Eligibility Overview. Trial Name: NCT05971719 — N/A

Pneumothorax Research Study Groups: Air Leaks

Pneumothorax Clinical Trial 2023: Air Leaks Highlights & Side Effects. Trial Name: NCT05971719 — N/A

Air Leaks 2023 Treatment Timeline for Medical Study. Trial Name: NCT05971719 — N/A

Frequently Asked Questions

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

Are there any remaining vacancies in this clinical trial?

"The latest information on clinicaltrials.gov states that this research study is not presently recruiting individuals. It was initially announced August 1st 2023, and the listing has since been updated July 25th 2023. That being said, there are other medical trials currently in need of participants to join their ranks."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Validation of a System Using Aerosol Glycerine to Detect and Localize Intraoperatively Pulmonary Air Leaks

2023. "Validation of a System Using Aerosol Glycerine to Detect and Localize Intraoperatively Pulmonary Air Leaks". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05971719.