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Composix Kugel Mesh Recall Leaves Unresolved Problems of Patient Management

NCT01520168 · Status: SUSPENDED · Type: OBSERVATIONAL · Enrollment: 21

Last updated 2012-03-13

No results posted yet for this study

Summary

From its introduction in 2000 until its US recall in December 2005, the Composix Kugel Mesh was implanted in an estimated 350,000 patients worldwide.

The purpose of the study is to evaluate retrospectively the complications related to this mesh that occurred in our patients between 2003 and 2005, since new complications continue to be diagnosed, although the investigators discontinued the use of the mesh.

Conditions

  • Incisional Hernia

Sponsors & Collaborators

  • University of Wuerzburg

    lead OTHER

Principal Investigators

  • Ulrich A. Dietz, MD, PhD · University of Wuerzburg

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-10-31
Primary Completion
2011-07-31
Completion
2012-03-31

Countries

  • Germany

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 NCT01520168 on ClinicalTrials.gov