NCT01855815

Hemolung RAS Registry Program

HL-CA-1600, Hemolung RAS Registry. A Retrospective Registry Involving Voluntary Reporting of De-identified, Standard of Care Data Following the Commercial Use of the Hemolung Respiratory Assist System (RAS)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 99 (estimated)
• Sponsor: Alung Technologies · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the Hemolung RAS Registry Program is to collect retrospective, de-identified, standard of care data following the commercial use of the Hemolung RAS.

Detailed description

ALung's post-market Hemolung RAS Registry Program provides a continuum for measuring the Hemolung RAS effectiveness and safety in a real-world setting beyond the results reported in pre-market clinical feasibility studies. The Hemolung RAS Registry Program is part of ALung's 1) evaluation of clinical evidence throughout the life cycle of the product, 2) longer term residual risk assessment of the product, and 3) commitment to maintain quality systems and integrate continuous quality improvements in the product. On a voluntary basis, participating physicians and institutional staff enter de-identified data online in the secure, password protected, regulatory-compliant Hemolung RAS Registry Portal in a retrospective manner following a patient's ICU discharge, status at 28 days post-Hemolung therapy, or death whichever is earlier. There is no requirement to collect and report data outside of standard of care. The program's methodology, data monitoring and statistical analysis plan is consistent with this type of initiative in a real-world setting.

Conditions

• Acute Hypercapnic Respiratory Failure

Timeline

• Start date: 2013-04-01
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2013-05-17
• Last updated: 2019-01-28