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Procedure
TorEx Lung Perfusion System for Lung Transplant
N/A
Waitlist Available
Led By Laura Donahoe, MD MSc FRCSC
Research Sponsored by University Health Network, Toronto
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 1 year post-transplant
Awards & highlights
Study Summary
This trial aims to improve lung transplantation outcomes by determining the safety and efficacy of the TorEx Lung Perfusion system for assessing donor lungs.
Who is the study for?
This trial is for individuals actively listed for a primary lung transplant, aged between 18 and 70. It's suitable if the donor lungs need extra evaluation to determine their fitness for transplantation. Candidates must consent in writing and cannot be part of another interventional trial or require multi-organ transplantation.Check my eligibility
What is being tested?
The TorEx Lung Perfusion System is being tested on up to 20 patients to see if it's safe and effective compared to the first generation Toronto EVLP system. This new system aims to better assess donor lungs that might otherwise be discarded.See study design
What are the potential side effects?
Since this study focuses on equipment rather than medication, side effects are related to potential complications from using assessed donor lungs in transplants, which may include typical transplant-related risks such as organ rejection or infection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year post-transplant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year post-transplant
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of ISHLT Primary Graft Dysfunction Grade 3
Secondary outcome measures
Forced expiratory volume - one second (FEV1 in L)
ICU and hospital length of stay
Occurrence of acute rejection
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Donor lungs assessed using TorEx Lung Perfusion SystemExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,468 Previous Clinical Trials
484,499 Total Patients Enrolled
Laura Donahoe, MD MSc FRCSCPrincipal InvestigatorUniversity Health Network, Toronto
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My donor is over 70 years old.My donor lungs require a special procedure to assess their function before transplant.I am receiving more than one organ transplant.I am between 18 and 80 years old.I am 70 years old or younger.The donor lungs I'm receiving are not ready for immediate transplant.I am on the active list for a first-time lung transplant.
Research Study Groups:
This trial has the following groups:- Group 1: Donor lungs assessed using TorEx Lung Perfusion System
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research protocol accept minors as participants?
"Candidates for this trial must be over 18 years old and under the age of 80."
Answered by AI
Is there an opportunity to join this medical experiment?
"Those with lung conditions and aged between 18-80 are eligible for this trial, which is looking to recruit approximately 20 patients."
Answered by AI
Is enrollment for this experiment still open to the public?
"Clinicaltrials.gov confirms that this trial is actively seeking enrolment, with its initial posting on December 6th 2022 and most recent update occurring on the 9th of that same month."
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What is the maximum capacity of participants for this research trial?
"Affirmative. According to information available on clinicaltrials.gov, enrollment for this medical trial is ongoing since being posted on December 6th 2022 and last updated December 9th 2022. The research expects to include 20 subjects from a single site."
Answered by AI
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