Registry Observing EndoBarrier® Treatment Outcomes in Subjects With Type 2 Diabetes and/or Obesity

Obesity Clinical Trial

Official title:

Registry Observing EndoBarrier® Treatment Outcomes in Subjects With Type 2 Diabetes and/or Obesity

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03072901
• Other study ID #: 10-3
• Status: Terminated
• Phase: N/A
• First received: January 19, 2017
• Last updated: March 2, 2017
• Start date: December 2010
• Est. completion date: February 2016

Study information

• Verified date: March 2017
• Source: GI Dynamics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The purpose of the registry was to observe the safety and effectiveness outcomes for subjects treated with the EndoBarrier in the post market setting where the product had Conformité Européene (CE mark) regulatory approval and in accordance to the approved Indication For Use.

Description:

This was a worldwide observational registry of the use of the EndoBarrier for inclusion of subjects treated with the EndoBarrier in centers in Australia, Chile, and the Netherlands. The registry was open to all subjects at participating centers that received the EndoBarrier.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 244
• Est. completion date: February 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• As per IFU, the EndoBarrier GI liner System is used for the treatment of obese type 2 diabetes with BMI greater than or equal to 30 kg/m2, or obese patients with BMI greater than or equal to 30 kg/m2 with less than or equal to 1 co-morbidities, or obese patients with BMI greater than 35 kg/m2. The GI liner is indicated for a maximum implant duration of 12 months.

Exclusion Criteria:

As per Instructions For Use (IFU)

• Women who are pregnant

• Requirement for prescription anticoagulation therapy

• History of inflammatory bowel disease or condition of the gastrointestinal tract, such as peptic ulcer disease (PUD), ulcers, or Crohn's disease

• Pancreatitis, Uncontrolled gastroesophageal reflux disease (GERD), Known infection at the time of implant

• Symptomatic coronary artery disease or pulmonary dysfunction

• History of coagulopathy

• Bleeding diathesis, upper GI bleeding conditions such as esophageal or gastric varices, or congenital or acquired intestinal telangiectasia

• Congenital or acquired anomalies of the GI tract such as atresias or stenosis

• Previous GI surgery that could affect the ability to place the EndoBarrier Gastrointestinal Liner or its function

• Iron deficiency and/or iron deficiency anemia

• Active symptoms of kidney stones or known presence of gallstones

• Inability to discontinue use of non-steroidal anti-inflammatory drugs during the implant period

• Family or patient history of known diagnosis or pre-existing condition of systemic lupus erythematosus, scleroderma, or other autoimmune connective tissue disorder

• H. pylori positive status (Patients may receive the EndoBarrier Gastrointestinal Liner if they had a prior history and were successfully treated)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity
• Type 2 Diabetes

Intervention

Device:
• EndoBarrier Gastrointestinal Liner
The EndoBarrier Gastrointestinal Liner (EndoBarrier) is a nonsurgical metabolic intervention for the treatment of Type 2 diabetes and obesity. By bypassing the duodenum and proximal jejunum, the device may alter signaling pathways that control metabolic processes.1, 2 The effect on patient's glucose levels is immediate as evidenced by meal tolerance testing.3 Since the device also promotes reduced appetite resulting in weight loss, the effect is maintained as the patient loses weight over the implant period. Most patients achieve normal HbA1c and fasting plasma glucose (FPG) levels rapidly within 3-6 months.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GI Dynamics

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events		24 months
Primary	Evaluation of Effectiveness of the EndoBarrier GI Liner upon glycemic control	Change in %HbA1c from Baseline	Change from Baseline measured up to 24 months
Primary	Evaluation of Effectiveness of the EndoBarrier GI Liner upon weight loss	Change from Baseline of weight (kg)	Change from Baseline measured up to 24 months