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

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.

Study Overview

• Status: Terminated
• Conditions: Obesity; Type 2 Diabetes
• Intervention / Treatment: Device: EndoBarrier Gastrointestinal Liner

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 244

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The registry was open to subjects who met the EndoBarrier's Indications for Use, inclusion/exclusion criteria and contraindications in the device's Instructions For Use at the time the Registry was initiated.

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

EndoBarrier Gastrointestinal Liner; 244 subjects; The registry will be open to subjects who meet the EndoBarrier's Indications for Use and none of the Contraindications in the device's Instructions For Use document. Subjects who successfully receive the device implant at a participating registry center will be included in the registry.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Adverse Events		24 months
Evaluation of Effectiveness of the EndoBarrier GI Liner upon glycemic control	Change in %HbA1c from Baseline	Change from Baseline measured up to 24 months
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

Collaborators and Investigators

• Sponsor: GI Dynamics
• Investigators: Study Director: Keith Gersin, MD, GI Dynamics, Medical Director

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: January 19, 2017
• First Submitted That Met QC Criteria: March 2, 2017
• First Posted (Actual): March 7, 2017

Study Record Updates

• Last Update Posted (Actual): March 7, 2017
• Last Update Submitted That Met QC Criteria: March 2, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Diabetes Mellitus; Diabetes Mellitus, Type 2; Obesity
• Other Study ID Numbers: 10-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes