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)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-31

Study Completion Date

2027-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Extracorporeal Membrane Oxygenation (ECMO) in Non-intubated Patients With Acute Respiratory Distress Syndrome (ARDS)

NCT01669863

ARDS

COMPLETED PHASE1/PHASE2

PREdiCtIon of Weanability, Survival and Functional outcomEs After ECLS

NCT05444764

Extracorporeal Membrane Oxygenation Extracorporeal Membrane Oxygenation Complication

RECRUITING

The Effect of NOn-invasive Respiratory Support on outcoMe and Its Risks in SARS-COV-2-related Hypoxemic Respiratory Failure

NCT06757166

Target Trial Emulation, Invasive Mechanical Ventilation

RECRUITING

Early-initiated High Flow Oxygen Therapy vs Conventional Oxygen Therapy Among Patients With ARDS in the Course of SARS-CoV2 Pneumonia.

NCT05197686

Corona Virus Infection ARDS Due to Disease Caused by Severe Acute Respiratory Syndrome Coronavirus 2 Oxygen Deficiency

UNKNOWN NA

Airway Clearance Using Non-Invasive Oscillating Device

NCT03821389

Respiratory Insufficiency

UNKNOWN PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardio-Respiratory Failure Extracorporeal Membrane Oxygenation Complication Acute Lung Injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Extracorporeal Life Support (ECLS)

Patients who receive ECLS treatment and require a ground-based inter- hospital patient transport and/ or stationary treatment on ECMO

Novalung ultimate kit, Xenios 2.0, and MultiSupport Ground (MSG)

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

1. If patient is able to give consent: by the study patient
2. If patient is unable to give consent: by the legal representative or
3. If an emergency situation is determined: by a consultant physician

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No