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SEAL Registry - European Registry for the Effectiveness of LifeSeal® Kit

NCT02881359 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2018-04-02

No results posted yet for this study

Summary

This study will assess the effectiveness of commercially available LifeSeal® Kit as measured by the incidence of post-operative clinical anastomotic leak rates in subjects undergoing low and ultralow anterior resection with an anastomosis. All patients treated with LifeSeal® will be offered to participate

Conditions

  • Anastomotic Leakage

Interventions

DEVICE

LifeSeal® Kit

used as an adjunct to suture or staple line during standard surgical repair of the GI tract (anastomosis or linear) to provide re-inforcement and help reduce leaks.

Sponsors & Collaborators

  • LifeBond Ltd.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2018-08-31
Completion
2018-09-30

Countries

  • Belgium
  • Netherlands

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 NCT02881359 on ClinicalTrials.gov