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The EndoBarrier Device: A 3-year Follow up Study

NCT02566330 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 10

Last updated 2016-07-11

No results posted yet for this study

Summary

The aim in the current proposal is to evaluate the long-term outcome of the EndoBarrier device. The group of participants the investigators want to study participated in earlier studies at the Maastricht University Medical Center (MUMC) and the Atrium Medical Center in Heerlen. Three years of follow-up after the EndoBarrier device is now available. The investigators hope to give new insights in the postoperative status and postoperative symptoms experienced by the study participants using standardised questionnaires and evaluating blood samples. The goal of the investigators is to study the long-term effect of the EndoBarrier procedure and to possibly provide insight in the relation between success/failure and objective parameters.

Conditions

Interventions

DEVICE

EndoBarrier

The device is a 60-cm long, impermeable plastic sleeve that is open at both sides so food can pass through. The sleeve is anchored in the duodenal bulb and extends partially into the jejunum. This way the pancreatic and bile juices will only mix with the food after the sleeve, hereby creating a functional bypass of the duodenum and the proximal jejunum, which causes malabsorption of nutrients.

Sponsors & Collaborators

  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • Nicole Bouvy, MD, PhD · Maastricht University Medical Center, The Netherlands

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • Netherlands

Study Locations

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Entities

Diseases

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 NCT02566330 on ClinicalTrials.gov