Cardio-Respiratory FailureTransport+NCT07156669
Safety and Performance of the Novalung Ultimate Kit and Xenios 2.0 During Stationary Use in Hospital and Ground-based Transport of Patients on Extracorporeal Life Support (ECLS)
An observational study of Cardio-Respiratory Failure and Extracorporeal Membrane Oxygenation Complication, run by Xenios AG at 3 sites in Germany.
Trial summary
This prospective observational study will evaluate the safety and performance of the Novalung ultimate kit in combination with the Xenios 2.0 and the MultiSupport Ground during stationary use in hospital and ground-based transport of patients treated on extracorporeal membrane oxygenation (ECMO). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardio-Respiratory Failure, Extracorporeal Membrane Oxygenation Complication, Acute Lung Injury
- What is being tested?
- Novalung ultimate kit, Xenios 2.0, and MultiSupport Ground (MSG)
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 3 sitesGermany
- Study dates
- 19 May 2026to Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with severe acute respiratory and/or cardiopulmonary failure treated on ECMO.
Who may be able to join
- Adult patients receiving an ECMO treatment with the Novalung ultimate kit in combination with the Xenios 2.0 (and the MultiSupport Ground during inter- and intra-hospital transport, if applicable) according to the intended use
- Informed consent signed and dated by the attending physician; and
- If patient is able to give consent: by the study patient
- If patient is unable to give consent: by the legal representative or
- If an emergency situation is determined: by a consultant physician
Who cannot join
- Participation in any interventional clinical study that could impact the results of this prospective, observational PMCF study
- Previous participation in the same study
- ECMO cannulation outside the referring or trial site hospital
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Fiona Bellando contact
Germany3 sites, 3 recruiting
- Recruiting
University Hospital Aachen
Aachen, 52074
Alexander Kersten, Dr. med., akersten@ukaachen.de
- Recruiting
Helios Klinikum Erfurt
Erfurt, Bavaria, 99089
Magdalena Römmer, Dr. med., +49 361 781-6075, magdalena.roemmer@helios-gesundheit.de
- Recruiting
Krankenhaus Bethanien gGmbH
Solingen, 42699
Winfried J. Randerath, Prof Dr med, randerath@klinik-bethanien.de
About this study
This prospective observational study will evaluate the safety and performance of the Novalung ultimate kit in combination with the Xenios 2.0 and the MultiSupport Ground during stationary use in hospital and ground-based transport of patients treated on extracorporeal membrane oxygenation (ECMO). The primary objective is to assess whether the use of the medical devices improves and maintains the gas exchange (blood oxygenation) in these patients. Medical Devices will be used according to their intended purpose and local standards/ requirements.
- Conditions
- Cardio-Respiratory Failure, Extracorporeal Membrane Oxygenation Complication, Acute Lung Injury
- Being tested
- Novalung ultimate kit, Xenios 2.0, and MultiSupport Ground (MSG)
- Keywords
- Extracorporeal Life Support, Extracorporeal Membrane Oxygenation
- Medical subject headings
- Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novalung ultimate kit, Xenios 2.0, and MultiSupport Ground (MSG)Device
Patients will receive ECLS treatment using the Novalung ultimate kit, Xenios 2.0, and MultiSupport Ground (MSG) during ground-based inter-hospital patient transport and/ or stationary treatment according to their intended use and local standards/ requirements.
| Study group | Role | What they receive |
|---|---|---|
| Extracorporeal Life Support (ECLS) | Patients who receive ECLS treatment and require a ground-based inter- hospital patient transport and/ or stationary treatment on ECMO Receives: Device: Novalung ultimate kit, Xenios 2.0, and MultiSupport Ground (MSG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial oxygen saturation (SaO2) [%]
Longitudinal assessments of continuous outcomes will be analyzed by treatment day using mixed models for repeated measures (MMRM), with ECMO mode as a fixed factor (except for analyses performed within the subsets defined by ECMO mode) and the baseline value of the primary endpoint as a covariate.
Within-subject differences between baseline and subsequent visits will be tested using contrasts. The comparison between baseline and the first day on ECMO (initial effect) is considered as the primary outcome.
Measured: Baseline and during the ECMO treatment every 24 hours until a maximum of 29 days
Secondary outcomes (5)
Performance objective Cardiacirculation
Improvement and maintenance of patients' cardiocirculation in patients transported and treated stationary on ECMO
Measured: Baseline and during the ECMO treatment every 24 hours until a maximum of 29 days
Performance objective Maintenance of blood flow
Evaluation of Xenios 2.0 performance during transport and stationary use: Maintenance of blood flow (L/min)
Measured: Baseline and during the ECMO treatment every 24 hours until a maximum of 29 days
Performance objective Pump speed
Evaluation of Xenios 2.0 performance during transport and stationary use: Pump speed (rpm)
Measured: Baseline and during the ECMO treatment every 24 hours until a maximum of 29 days
Performance objective Circuit pressures
Evaluation of Xenios 2.0 performance during transport and stationary use: Circuit pressures (mmHg)
Measured: Baseline and during the ECMO treatment every 24 hours until a maximum of 29 days
Safety objectives
Assessment of the safety of the use of the Xenios System for ground-based transport and stationary use of patients on ECMO.
Complications will be grouped in device-, transport-, cannula-, and patient-related complications and presented as relative and absolute frequencies.
Measured: Baseline and during the ECMO treatment every 24 hours until a maximum of 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start19 May 2026
- Primary completionApr 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardio-Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xenios AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Alcedis GmbH
- Responsible party
- Sponsor
- Investigators
- Magdalena Römmer, Dr. med., Principal investigator, HELIOS Hospital, Erfurt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07156669
- Sponsor's protocol ID
- HL-ECMO-01-INT
- Acronym
- Transport+
- Status last verified
- Sep 2026
- First submitted
- 5 Jun 2025
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Performance of the Novalung Ultimate Kit and Xenios 2.0 During Stationary Use in Hospital and Ground-based Transport of Patients on Extracorporeal Life Support (ECLS)
- ClinicalTrials.gov ID
- NCT07156669
- Acronym / sponsor ID
- Transport+ / HL-ECMO-01-INT
- Conditions
- Cardio-Respiratory Failure, Extracorporeal Membrane Oxygenation Complication, Acute Lung Injury
- Keywords
- Extracorporeal Life Support, Extracorporeal Membrane Oxygenation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Xenios AGIndustry (pharma, biotech, devices)
- Collaborators
- Alcedis GmbH
- Study start
- 19 May 2026 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 5 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective observational study will evaluate the safety and performance of the Novalung ultimate kit in combination with the Xenios 2.0 and the MultiSupport Ground during stationary use in hospital and ground-based transport of patients treated on extracorporeal membrane oxygenation (ECMO). The primary objective is to assess whether the use of the medical devices improves and maintains the gas exchange (blood oxygenation) in these patients. Medical Devices will be used according to their intended purpose and local standards/ requirements.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Extracorporeal Life Support (ECLS) | – | Device: Novalung ultimate kit, Xenios 2.0, and MultiSupport Ground (MSG)Patients who receive ECLS treatment and require a ground-based inter- hospital patient transport and/ or stationary treatment on ECMO |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with severe acute respiratory and/or cardiopulmonary failure treated on ECMO.
Key inclusion criteria (5 listed)
- Adult patients receiving an ECMO treatment with the Novalung ultimate kit in combination with the Xenios 2.0 (and the MultiSupport Ground during inter- and intra-hospital transport, if applicable) according to the intended use
- Informed consent signed and dated by the attending physician; and
Key exclusion criteria (3 listed)
- Participation in any interventional clinical study that could impact the results of this prospective, observational PMCF study
- Previous participation in the same study
- ECMO cannulation outside the referring or trial site hospital
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Novalung ultimate kit, Xenios 2.0, and MultiSupport Ground (MSG)Patients will receive ECLS treatment using the Novalung ultimate kit, Xenios 2.0, and MultiSupport Ground (MSG) during ground-based inter-hospital patient transport and/ or stationary treatment according to their intended use and local standards/ requirements. | Device | Extracorporeal Life Support (ECLS) |
Primary outcome
Arterial oxygen saturation (SaO2) [%]
Time frame: Baseline and during the ECMO treatment every 24 hours until a maximum of 29 days
Longitudinal assessments of continuous outcomes will be analyzed by treatment day using mixed models for repeated measures (MMRM), with ECMO mode as a fixed factor (except for analyses performed within the subsets defined by ECMO mode) and the baseline value of the primary endpoint as a covariate. Within-subject differences between baseline and subsequent visits will be tested using contrasts. The comparison between baseline and the first day on ECMO (initial effect) is considered as the primary outcome.
5 secondary outcomes
Performance objective Cardiacirculation
Time frame: Baseline and during the ECMO treatment every 24 hours until a maximum of 29 days
Performance objective Maintenance of blood flow
Time frame: Baseline and during the ECMO treatment every 24 hours until a maximum of 29 days
Performance objective Pump speed
Time frame: Baseline and during the ECMO treatment every 24 hours until a maximum of 29 days
Performance objective Circuit pressures
Time frame: Baseline and during the ECMO treatment every 24 hours until a maximum of 29 days
Safety objectives
Time frame: Baseline and during the ECMO treatment every 24 hours until a maximum of 29 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fiona Bellando contact
Magdalena Römmer, Dr. med. principal investigator
HELIOS Hospital, Erfurt, Germany
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardio-Respiratory Failure and Extracorporeal Membrane Oxygenation Complication, run by Xenios AG at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anja Derlet-Savoia, Dr. (+49 6172 268 6648, Anja.Derlet@freseniusmedicalcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arterial oxygen saturation (SaO2) [%] (time frame: Baseline and during the ECMO treatment every 24 hours until a maximum of 29 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.