NCT07340710

Decreasing Edema With a Novel OCS Solution Trial

Decreasing Edema With a Novel OCS Solution (DENOVO) Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: TransMedics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multicenter randomized trial of lung transplant recipients transplanted with either a DBD or DCD donor lungs. The DENOVO Trial will enroll a total of 300 patients in the OCS arm and 150 patients in the SCS arm. The primary endpoint will be patient \& graft survival and freedom of Primary Graft Dysfunction (PGD) grade 3 within the initial 72 hours post-transplantation.

Conditions

• Lung Transplant

Interventions

Type	Name	Description
DEVICE	OCS Lung System	Donor lungs preserved on OCS Lung System
OTHER	Static Cold Storage	Donor Lungs preserved on Static Cold Storage

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-12-01
• Completion: 2028-02-01
• First posted: 2026-01-14
• Last updated: 2026-01-14

Regulatory

• FDA-regulated device study