Evaluating a special oxygenator for COVID-19 patients
ECMO Braile Biomédica® in COVID-19 Patients Post-market Clinical Trial to Verify the Performance of the ECMO System
This study is testing a special oxygen machine to see how well it helps adults with severe breathing problems from COVID-19.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Braile Biomedica Ind. Com. e Repr. Ltda. Industry-sponsored |
| Locations | 1 site (Lago Sul, Brasília - DF) |
| Trial ID | NCT06086405 on ClinicalTrials.gov |
What this trial studies
This observational study collects retrospective data to assess the gas transfer capacity of the Braile Biomédica® OxyPrime® ECMO BRCoating® Membrane Oxygenator in adult patients diagnosed with COVID-19. It is a multicenter, non-comparative, and non-randomized study that focuses on the clinical performance of this specific ECMO device during the pandemic. The study aims to provide insights into the effectiveness of this technology in supporting patients with severe respiratory issues caused by COVID-19.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have been diagnosed with COVID-19 and received ECMO support using the OxyPrime® device.
Not a fit: Patients without a diagnosis of COVID-19 will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of ECMO technology's effectiveness in treating severe COVID-19 cases, potentially improving patient outcomes.
How similar studies have performed: While there have been various studies on ECMO in COVID-19 patients, this specific evaluation of the Braile Biomédica® device is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients ≥ 18 years old, with a previous diagnosis of COVID-19, who were placed on ECMO using the Oxyprime® ECMO Braile Biomédica® Membrane Oxygenator, from March 2020 to July 2022, following the Instructions for Use (IFU) of the products. Exclusion Criteria: * Patients without a diagnosis of COVID-19
Where this trial is running
Lago Sul, Brasília - DF
- Hospital Brasília — Lago Sul, Brasília - DF, Brazil (Recruiting)
Study contacts
- Principal investigator: Vitor S Barzila — Hospital Brasília
- Study coordinator: Glacia G Basso
- Email: glaucia.basso@braile.com.br
- Phone: +55(17)2136-7005
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.