The Effect of the EndoBarrier Device: A 3-year follow-up of a randomized clinical trial.

The Effect of the EndoBarrier Device: A 3-year follow-up of a randomized clinical trial. - The EndoBarrier follow-up study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON41836

Enrollment

Registered

2015-06-30

Start date

2015-09-29

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1) Patients who were previously enrolled in the randomized clinical EndoBarrier procedure trial at the MUMC or the Atrium Medical Centre Heerlen regardless of their excess weight loss 2) Patients who have a follow up of at least 3 years. 3) Signed informed consent

Exclusion criteria

Exclusion criteria: 1) Post-EndoBarrier conventional bariatric surgery 2) Patients who were lost to follow-up during the previous conducted Endobarrier clinical trial

Design outcomes

Primary

Measure	Time frame
The percentage of Excessive weight loss to assess the impact of the EndoBarrier on body weight three years after explantation	—

Secondary

Measure	Time frame
- To assess the Effectiveness of the EndoBarrier device three years after explantation on lowering risk factors associated with morbid obesity. - To assess long-term patient satisfaction after the EndoBarrier device. - To assess long-term quality of life in patients after the EndoBarrier device. - To assess the concentration of fibroblast growth factor 19 (FGF19), total bile salts and bile salts composition in human plasma samples measured using immunological (ELISA) and enzymatic assays, respectively.	—

Measure

Time frame

- To assess the Effectiveness of the EndoBarrier device three years after explantation on lowering risk factors associated with morbid obesity. - To assess long-term patient satisfaction after the EndoBarrier device. - To assess long-term quality of life in patients after the EndoBarrier device. - To assess the concentration of fibroblast growth factor 19 (FGF19), total bile salts and bile salts composition in human plasma samples measured using immunological (ELISA) and enzymatic assays, respectively.

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Countries

Netherlands

Outcome results