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NCT05101460 · ClinicalTrials.gov registry record

An All Comers Registry For Normothermic Ex Vivo Lung Perfusion (EVLP) as Assessment of Donor Lungs for Transplant

A clinical trial of Lung Transplant, sponsored by XVIVO Perfusion.

Recruiting
Registry status
315
Enrollment target
1
Study location

NCT05101460 is a study of Lung Transplant that is actively recruiting participants, run by XVIVO Perfusion. The registered enrollment target is 315 participants, below the 1,255-participant average among 15 other Lung Transplant trials with a reported enrollment target (75% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05101460, a study of Lung Transplant, is actively recruiting participants, sponsored by XVIVO Perfusion.

RECRUITING
Registry status
315 participants
Enrollment target
1
Study location

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

FieldValue
Enrollment Target 315 participants
Start Date 2019-10-29
Est. Completion 2029-04-24

Sponsor

XVIVO Perfusion

3 total trials

What the Registry Record Tells You About NCT05101460

The ClinicalTrials.gov registry entry for NCT05101460 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 315 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,255-participant average among 15 other Lung Transplant trials with a reported enrollment target (75% lower). The listed sponsor is XVIVO Perfusion, which has 3 total studies on file at ClinicalTrials.gov.

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.

NCT05101460 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.

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.

What interventions are being tested in trial NCT05101460?

The interventions under investigation include: XVIVO Perfusion System (XPS™) with STEEN Solution™ (DEVICE).

Who is sponsoring clinical trial NCT05101460?

This trial is sponsored by XVIVO Perfusion, which has 3 total clinical trials registered on ClinicalTrials.gov.

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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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