Status:
COMPLETED
Treatment of Morbidly Obese Adolescent With a Duodena-jejunal Liner
Lead Sponsor:
University Medical Centre Ljubljana
Conditions:
Obesity
Diabetes
Eligibility:
All Genders
16-20 years
Phase:
PHASE3
Brief Summary
Obesity and its complications have a significant effect on morbidity and mortality in these subjects. Especially at risk are subjects with extremely increased BMI (above 99th percentile for age and ge...
Eligibility Criteria
Inclusion
- Subjects estimated to fully comply with study protocol and have signed an informed consent form.
- Age \> 15 years.
- BMI ≥ 99. percentile for age and gender.
- Inefficient conservative measures (of at least 6 months duration) to decrease body weight (characterized as a decrease in BMI \> 10 %).
- Documented negative pregnancy test in women of childbearing potential.
- Women of childbearing potential agree to remain on contraceptives for the duration of their trial participation.
Exclusion
- Previous GI surgery that could potentially affect the ability to place sleeve or affect the function of the implant.
- Subjects with congenital or acquired anomalies of the GI tract which in the opinion of the investigator, may impair implantation of the EndoBarrier device.
- Subjects who had gastrooesophageal reflucs disease..
- Known abnormal pathologies or conditions of the gastrointestinal tract, including ulcers or Crohn's disease, upper gastro-intestinal bleeding conditions.
- Coagulopathy defined as Hgb \<10g/dl and platelet \< 100,000/ml or diagnosis of other severe coagulopathy like hemophilia.
- Any documented history of acute or chronic pancreatitis.
- Subjects requiring regular antithrombotic therapy (i.e. anticoagulant or antiplatelet agent).
- Known diagnosis of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder.
- Subject is or has been enrolled in another investigational study within 6 months of participation into the EndoBarrier study.
- Subjects who are mentally retarded or emotionally unstable.
- Subjects who are pregnant or were breastfeeding.
- Subjects with an abnormal laboratory or ECG abnormality which the investigators deems clinically significant and makes the patient a poor candidate for the study.
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2018
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT02183935
Start Date
July 1 2014
End Date
December 20 2018
Last Update
July 10 2020
Active Locations (1)
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1
UMC Ljubljana
Ljubljana, Slovenia