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An All Comers Registry For Normothermic Ex Vivo Lung Perfusion (EVLP) as Assessment of Donor Lungs for Transplant
NCT05101460 · View on ClinicalTrials.gov ↗
Study Summary
The XVIVO Registry is to collect standard of care clinical data from "all-comers" who are transplanted with an EVLP lung treated with the XVIVO Perfusion System™ in order to assess the long-term performance of the device, and monitor device-related serious adverse events. In addition, 4 and 5-year UNOS registry data of the 126 subjects who received an EVLP transplant under the NOVEL and NOVEL Extension studies are provided as part of the long-term safety and quality of life data. In addition, 4 and 5-year UNOS registry data of the 126 subjects who received an EVLP transplant under the NOVEL and NOVEL Extension studies are provided as part of the long-term safety and quality of life data.
Conditions Studied
Interventions
- DEVICE XVIVO Perfusion System (XPS™) with STEEN Solution™
Study Locations (1)
Ohio
- Cleveland Clinic Foundation — Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 315 participants |
| Start Date | 2019-10-29 |
| Est. Completion | 2029-04-24 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05101460
The ClinicalTrials.gov registry entry for NCT05101460 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 315 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is XVIVO Perfusion, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Lung Transplant appearing as the primary indexed condition, and to 1 intervention — of which XVIVO Perfusion System (XPS™) with STEEN Solution™ is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05101460 reports 1 study location spanning 1 distinct geographic area — top geographies include Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05101460 about?
NCT05101460 is a clinical study titled "An All Comers Registry For Normothermic Ex Vivo Lung Perfusion (EVLP) as Assessment of Donor Lungs for Transplant". The XVIVO Registry is to collect standard of care clinical data from "all-comers" who are transplanted with an EVLP lung treated with the XVIVO Perfusion System™ in order to assess the long-term performance of the device, and monitor device-related serious adverse events. In addition, 4 and 5-year U...
What is the current status of trial NCT05101460?
This trial is currently recruiting. The enrollment target is 315 participants. The study started on 2019-10-29. Estimated completion is 2029-04-24.
What conditions does trial NCT05101460 study?
This clinical trial studies the following conditions: Lung Transplant. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05101460?
The interventions under investigation include: XVIVO Perfusion System (XPS™) with STEEN Solution™ (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05101460?
This trial is sponsored by XVIVO Perfusion, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05101460 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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