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Hemopatch Performance Evaluation: A Prospective Observational Registry

NCT03392662 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 621

Last updated 2022-11-16

No results posted yet for this study

Summary

To assess the clinical performance and safety of HEMOPATCH Sealing Hemostat in a post-marketing setting in cardiovascular, thoracic, urologic, neurological, and other general surgical procedures.

Conditions

  • Dura Mater Nick Cut or Tear
  • Hemostatis
  • Air Leakage
  • Body Fluid Leakage

Interventions

DEVICE

Hemopatch

Patients received product at the discretion of their surgeon.

Sponsors & Collaborators

  • Baxter Healthcare Corporation

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-29
Primary Completion
2019-01-28
Completion
2019-01-28
FDA Device
Yes

Countries

  • Austria
  • Czechia
  • Germany
  • Italy
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03392662 on ClinicalTrials.gov