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Use of Seamguard to Prevent Leak and Bleeding in Gastrointestinal Surgery

NCT01180140 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 113

Last updated 2010-08-11

No results posted yet for this study

Summary

The purpose of this study is to determinate the utility of staple-line reinforcement on lineal gastrointestinal anastomoses.

Hypothesis: Seamguard device will decrease the incidence of leak and bleeding in digestive lineal stapled anastomoses.

Conditions

  • Leak on Lineal Stapled Anastomoses
  • Bleeding on Lineal Stapled Anastomoses

Interventions

DEVICE

Seamguard

GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement is specifically engineered to reduce the incidence of perioperative leaks and bleeding in a variety of open and minimally invasive surgeries. Then, after six months, it is completely absorbed eliminating the risk of a prolonged inflammatory response.

Sponsors & Collaborators

  • Unidad mixta de Investigación HUC-ULL

    collaborator UNKNOWN

  • University of La Laguna

    collaborator OTHER

  • Hospital Universitario de Canarias

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2009-08-31
Completion
2010-06-30

Countries

  • 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 NCT01180140 on ClinicalTrials.gov