The EndoBarrier Device: A 3-year Follow up Study

NCT02566330 | Completed DMC

• 1 other identifier: NL51074.068.14
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Obesity; Diabetes

Keywords

EndoBarrier; Duodenojejunal Bypass Liner

Outcome Measures

Primary Outcomes (1)

• Excess Weight (%)

  36 months post explant EndoBarrier Liner

Secondary Outcomes (22)

• Insulin levels (mmol/L)

  36 months post explant EndoBarrier Liner

• Total Cholesterol (mmol/L)

  36 months post explant EndoBarrier Liner

• SF-36 health related quality of life, patient-reported survey of patient health

  36 months post explant EndoBarrier Liner

• FGF 19 (ng/ml)

  36 months post explant EndoBarrier Liner

• ASAT (U/L)

  36 months post explant EndoBarrier Liner

Study Arms (1)

EndoBarrier

Participants who were previously enrolled in the randomized clinical EndoBarrier procedure trial at the MUMC and the Atrium Medical Centre Heerlen.

Device: EndoBarrier

Interventions

EndoBarrier DEVICE

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.

EndoBarrier

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In this observational follow-up study of a randomized clinical trial a maximum of 29 participants may be included who were previously enrolled in the EndoBarrier device study at the MUMC or the Atrium Medical Centre Heerlen.

You may qualify if:

• Participants who were previously enrolled in the randomized clinical EndoBarrier procedure trial at the MUMC and the Atrium Medical Centre Heerlen regardless of their excess weight loss.
• Participants who have a follow up of at least 3 years.
• Signed informed consent.

You may not qualify if:

• Post-EndoBarrier conventional bariatric surgery
• Participants who were lost to follow-up during the previous conducted EndoBarrier clinical trial.

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 6229 HX, Netherlands

Location

MeSH Terms

Conditions

Obesity; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Nicole Bouvy, MD, PhD

  Maastricht University Medical Center, The Netherlands

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 15, 2015
• First Posted: October 2, 2015
• Study Start: October 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: July 11, 2016

Record last verified: 2016-07

Locations

NL (1)