← Back to Search

Organ Preservation Device

Standard Donor Lungs Primary Analysis Population for Lung Transplant (TOP Trial)

N/A
Recruiting
Research Sponsored by TransMedics
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 1,6,12,24,36,48,60 months
Awards & highlights

Summary

Single-arm, prospective, multi-center, post-approval U.S. registry

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1,6,12,24,36,48,60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1,6,12,24,36,48,60 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
12-month patient and graft survival post double-lung transplant
Secondary study objectives
Donor Lungs Initially Deemed Unacceptable - Donor Lung Utilization Rate
Donor Lungs Initially Deemed Unacceptable - Incidence of PGD3 at 72 hours post-transplantation
Donor Lungs Initially Deemed Unacceptable - Incidence of PGD3 within the initial 72 hours post-transplantation
+2 more
Other study objectives
Kaplan-Meier BOS-free survival estimated at Month 12, 24, 36, 48 and 60
Kaplan-Meier Freedom from BOS estimated at Month 12, 24, 36, 48 and 60
Kaplan-Meier graft survival (freedom from re-transplant/graft failure) at Month 12, 24, 36, 48 and 60
+6 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Standard Donor Lungs Primary Analysis PopulationExperimental Treatment1 Intervention
Recipients transplanted with primary analysis population eligible donor lungs preserved on the OCS™ Lung System.
Group II: Donor Lungs Initially Unacceptable Primary Analysis Pop.Experimental Treatment1 Intervention
Recipients transplanted with primary analysis population eligible donor lungs preserved on the OCS™ Lung System.
Group III: All Other Enrolled PatientsExperimental Treatment1 Intervention
All OCS Lung transplanted patients that do not meet any of the above analysis populations.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
OCS Lung System
2018
N/A
~300

Find a Location

Who is running the clinical trial?

TransMedicsLead Sponsor
23 Previous Clinical Trials
118,016 Total Patients Enrolled
2 Trials studying Lung Transplant
10,079 Patients Enrolled for Lung Transplant
~139 spots leftby Aug 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top